Downloaded from http://aim.bmj.com/ on June 26, 2015 - Published by group.bmj.com
Original paper
Developing an acupuncture protocol for treating phantom limb pain: a Delphi consensus study Esmé G Trevelyan, Warren A Turner, Nicola Robinson
▸ Additional material is published online only. To view please visit the journal online (http://dx.doi.org/10.1136/ acupmed-2014-010668). Faculty of Health and Social Care, London South Bank University, London, UK Correspondence to Esmé Trevelyan, Faculty of Health and Social Care, London South Bank University, 103 Borough Road, London SE1 0AA, UK; [email protected] Received 11 September 2014 Revised 12 November 2014 Accepted 15 November 2014 Published Online First 8 December 2014
To cite: Trevelyan EG, Turner WA, Robinson N. Acupunct Med 2015;33: 42–50.
42
ABSTRACT Background Little is known about how a Traditional Chinese Medicine (TCM) approach could be used to treat phantom limb pain (PLP). There is currently no standard acupuncture protocol in the literature to treat this syndrome. Objectives To achieve consensus among a group of acupuncture practitioners on the pathology and recommended treatment of PLP and devise an acupuncture protocol for the treatment of this condition. Methods A classical Delphi approach was used using two parallel online Delphi studies. One study focused on participants with past experience of treating PLP (TPLP, n=7) and the other on practitioners with no past experience (NTPLP, n=16). Two hypothetical case studies were provided and participants were asked for responses on how they would treat these patients. Three rounds were included. Participants were also invited to rate and comment on the finalised protocol. Round 1 data were analysed using content analysis. In subsequent rounds an a priori criterion for defining consensus was set at ≤1.75 IQR. A group median of 5–6 was considered to mean ‘agree’. Results 19 participants completed all Delphi rounds (12 NTPLP, 7 TPLP). 108 NTPLP and 76 TPLP statements were generated and circulated in round 2; 53% of the NTPLP statements and 62% of the TPLP statements met consensus in round 2 and 45% of the NTPLP statements and 44% of the TPLP statements met consensus in round 3. Participants all agreed with the final protocol developed. Conclusions The protocol developed does not claim to be best practice but provides a preliminary consensus from practitioners practising acupuncture for the treatment of PLP.
INTRODUCTION Silas Weir Mitchell (1829–1914) coined the term ‘phantom limb syndrome’, but the phenomenon was recorded medically
prior to this by Ambroise Paré (1510– 1590).1 Currently, most literature tends to focus on two categories of amputation-related pain: phantom limb pain (PLP) and residual pain. Phantom sensations are non-painful sensations.2 Both PLP and phantom sensations may exist simultaneously.3 The incidence of PLP in the UK has been estimated at 0.1 per 10 000 personyears,4 and recent large surveys suggest 75% of amputees suffer PLP.5 However, reports on the prevalence of PLP vary considerably, possibly due to differences in methodologies, time points of assessment, definition and cut-off values used for diagnosis and the study population.6 PLP involves multiple changes along the neuroaxis.7 Peripheral mechanisms include formation of neuroma and ectopic discharge.8 Noxious stimuli due to nerve injury sensitise central structures and cause central sensitisation, wind-up, long-term potentiation and expansion of receptive fields of the central neurons.9 Central sensitisation is characterised by reduction of inhibitory processes, increased excitability of the dorsal horn neurons and structural changes at the central nerve endings.10 Amputation alters neuronal activity in cortical and subcortical structures,11 and changes and distortion occur in cortical maps.9 Reorganisation of the somatosensory cortex occurs surrounding the area representing the deafferenated limb.12 Cortical fields deprived of input shrink and the receptive field becomes smaller. Adjacent representations from nondenervated parts of the body then take over the cortical field.9 Evidence for the successful treatment of PLP is inconsistent. In the UK, common first-line treatments include amitriptyline, gabapentin and pregabalin.4 However, the short-term and long-term effectiveness of
Trevelyan EG, et al. Acupunct Med 2015;33:42–50. doi:10.1136/acupmed-2014-010668
Downloaded from http://aim.bmj.com/ on June 26, 2015 - Published by group.bmj.com
Original paper these treatments remains unclear, with gabapentin demonstrating a trend towards short-term analgesic efficacy and amitriptyline being ineffective.13 Acupuncture has been shown to be effective in the treatment of chronic pain conditions14 but has not been well documented for treating PLP.15 The style of acupuncture and point choice varies widely in the literature.16 Three main consensus approaches are recognised in health research: the Delphi method, nominal group technique and consensus development conference.17 The Delphi technique has the advantage of not requiring face-to-face contact, so facilitating input from a wider group of participants.18 It is well suited to research in which there is incomplete knowledge about a problem or phenomenon and works well when the goal of research is to improve understanding.19 20 The Delphi technique was used in this study to gain agreement on acupuncture principles and to develop a protocol for the treatment of PLP which could be used in future trials and clinical practice. METHODS As a broad understanding of views on treatment was sought, participants both with and without previous experience in treating PLP were included in the study and two parallel surveys were run ( past experience of treating PLP (TPLP) and no prior experience of treating PLP (NTPLP)). A classical Delphi approach using an open first round to facilitate the generation of ideas21 was taken and delivered online. The study was approved by London South Bank University Research Ethics Committee in September 2013, piloted in October 2013, commenced in November 2013 and completed in March 2014. Recruitment
Professional acupuncture associations (British Acupuncture Council, Association of Traditional Chinese Medicine and Acupuncture Association of Chartered Physiotherapists) and universities teaching acupuncture were provided with information about the study and asked to forward information to members/past students. Any participant who contacted the researcher about the study was provided with information. An email sent back by the participant was taken as consent to participate. Convenience and snowball sampling was used to capture as many participants as possible with past experience of treating PLP. Inclusion criteria included: completion of recognised training in acupuncture, registered with a professional body, at least 3 years clinical experience, and the ability to communicate in English. With Delphi studies it is recommended that, for a homogeneous sample, a small sample size is appropriate, such as 10–1520 or 8–12 participants,21 and the study aimed to recruit approximately this number in each group.
Trevelyan EG, et al. Acupunct Med 2015;33:42–50. doi:10.1136/acupmed-2014-010668
Procedure
The study was quasi-anonymous (the principal researcher (ET) knew which response came from which participant but participants did not). An a priori criterion of three rounds of Delphi was set. A fourth anonymous round was included involving rating and commenting on the finalised protocol. Participants were asked to respond to each round within 7–10 days and each round closed after 2 weeks. Subsequent rounds were sent out 2 weeks after closure of the previous round. All questionnaires were developed using the Bristol Online Survey (http://www.survey.bris.ac.uk). Round 1 questionnaire consisted of two hypothetical case studies and 12 open-ended questions per case. Rounds 2 and 3 included statements generated from analysis of round 1. A ‘no comment’ option was provided if participants did not feel qualified to rank a statement. Statements were ranked on a 6-point Likert scale (from strongly disagree to strongly agree). Round 3 also provided additional information: response from the last round, median and IQR. To minimise participant fatigue, questions for which ≥50% of the ranked statements had met consensus in round 2 were not included in round 3 unless agreement had not been met. Analysis of data
Qualitative data were analysed using NVIVO 10 and quantitative data using SPSS V.21. In round 1 qualitative content analysis was used, using thematic criteria.22 Raw data were condensed, and grouped and condensed statements which only appeared once were excluded from round 2. Two researchers (ET and NR) discussed and reviewed the grouped statements to ensure meaning was not lost or biased through researcher interpretation. A consistency check of coding was applied by testing intra-rater reliability 10–14 days after initial coding (ET). Inter-rater reliability was checked through a second coder (NR) who coded a portion of the data. In subsequent rounds an a priori criterion for defining consensus and agreement was set. A group median of 5–6 was considered to mean ‘agree’ and an IQR ≤1.75 was considered indicative of consensus.23 Stability of results was assessed using a Wilcoxon matched pairs signed rank test. The results were deemed stable when there was no significant difference between items.23 A p value ≤0.05 was used in this study. To maximise validity, SD was recorded to demonstrate convergence of results. Round 3 NTPLP and TPLP results were compared to allow for comparison and triangulation between groups. RESULTS Figure 1 shows participant flow throughout the Delphi process. A total of 37 practitioners initially expressed interest in participating; 23 completed round 1 (the
43
Downloaded from http://aim.bmj.com/ on June 26, 2015 - Published by group.bmj.com
Original paper
Figure 1 Flow chart of participants through the study. TPLP, practitioners with past experience of treating phantom limb pain; NTPLP, practitioners with no past experience of treating phantom limb pain.
TPLP group only managed to recruit seven participants), 19 completed both rounds 2 and 3 (12 acupuncturists, 6 physiotherapists practising acupuncture, 1 acupuncturist and physiotherapist) and 17 rated the final protocol. The reason for attrition by the 14 practitioners who did not complete round 1 was sought. A total of 12 responded with 7 reporting lack of time. Table 1 shows the demographics of the participants. All participants had completed acupuncture training in the UK; most practised a combination of Traditional Chinese Medicine (TCM) and 5 Element acupuncture. In the TPLP group, six practised TCM±other acupuncture styles and, in the NTPLP group, 12 practised TCM ±other acupuncture styles. Those who did not practise TCM practised Western medical acupuncture (n=5). In the TPLP group, six were acupuncturists±physiotherapists and one was a physiotherapist. In the NTPLP group, eight were acupuncturists and eight were physiotherapists. Figure 2 provides data on the number of statements included in each round and the number of statements meeting consensus throughout the rounds. In round 1, 619 NTPLP statements and 292 TPLP statements were generated which were condensed down to 204 and 135 statements, respectively. Of the condensed statements, 96 were omitted in the NTPLP group as they did not meet the threshold for inclusion in round 2 (ie, only appeared once) and, in the TPLP group,
44
59 were omitted for the same reason. Of the statements included in round 2, 53% of NTPLP statements and 62% of TPLP statements met consensus and, in round 3, 45% of NTPLP statements and 44% of TPLP statements met consensus. The ‘no comment’ option was selected
Original paper
Developing an acupuncture protocol for treating phantom limb pain: a Delphi consensus study Esmé G Trevelyan, Warren A Turner, Nicola Robinson
▸ Additional material is published online only. To view please visit the journal online (http://dx.doi.org/10.1136/ acupmed-2014-010668). Faculty of Health and Social Care, London South Bank University, London, UK Correspondence to Esmé Trevelyan, Faculty of Health and Social Care, London South Bank University, 103 Borough Road, London SE1 0AA, UK; [email protected] Received 11 September 2014 Revised 12 November 2014 Accepted 15 November 2014 Published Online First 8 December 2014
To cite: Trevelyan EG, Turner WA, Robinson N. Acupunct Med 2015;33: 42–50.
42
ABSTRACT Background Little is known about how a Traditional Chinese Medicine (TCM) approach could be used to treat phantom limb pain (PLP). There is currently no standard acupuncture protocol in the literature to treat this syndrome. Objectives To achieve consensus among a group of acupuncture practitioners on the pathology and recommended treatment of PLP and devise an acupuncture protocol for the treatment of this condition. Methods A classical Delphi approach was used using two parallel online Delphi studies. One study focused on participants with past experience of treating PLP (TPLP, n=7) and the other on practitioners with no past experience (NTPLP, n=16). Two hypothetical case studies were provided and participants were asked for responses on how they would treat these patients. Three rounds were included. Participants were also invited to rate and comment on the finalised protocol. Round 1 data were analysed using content analysis. In subsequent rounds an a priori criterion for defining consensus was set at ≤1.75 IQR. A group median of 5–6 was considered to mean ‘agree’. Results 19 participants completed all Delphi rounds (12 NTPLP, 7 TPLP). 108 NTPLP and 76 TPLP statements were generated and circulated in round 2; 53% of the NTPLP statements and 62% of the TPLP statements met consensus in round 2 and 45% of the NTPLP statements and 44% of the TPLP statements met consensus in round 3. Participants all agreed with the final protocol developed. Conclusions The protocol developed does not claim to be best practice but provides a preliminary consensus from practitioners practising acupuncture for the treatment of PLP.
INTRODUCTION Silas Weir Mitchell (1829–1914) coined the term ‘phantom limb syndrome’, but the phenomenon was recorded medically
prior to this by Ambroise Paré (1510– 1590).1 Currently, most literature tends to focus on two categories of amputation-related pain: phantom limb pain (PLP) and residual pain. Phantom sensations are non-painful sensations.2 Both PLP and phantom sensations may exist simultaneously.3 The incidence of PLP in the UK has been estimated at 0.1 per 10 000 personyears,4 and recent large surveys suggest 75% of amputees suffer PLP.5 However, reports on the prevalence of PLP vary considerably, possibly due to differences in methodologies, time points of assessment, definition and cut-off values used for diagnosis and the study population.6 PLP involves multiple changes along the neuroaxis.7 Peripheral mechanisms include formation of neuroma and ectopic discharge.8 Noxious stimuli due to nerve injury sensitise central structures and cause central sensitisation, wind-up, long-term potentiation and expansion of receptive fields of the central neurons.9 Central sensitisation is characterised by reduction of inhibitory processes, increased excitability of the dorsal horn neurons and structural changes at the central nerve endings.10 Amputation alters neuronal activity in cortical and subcortical structures,11 and changes and distortion occur in cortical maps.9 Reorganisation of the somatosensory cortex occurs surrounding the area representing the deafferenated limb.12 Cortical fields deprived of input shrink and the receptive field becomes smaller. Adjacent representations from nondenervated parts of the body then take over the cortical field.9 Evidence for the successful treatment of PLP is inconsistent. In the UK, common first-line treatments include amitriptyline, gabapentin and pregabalin.4 However, the short-term and long-term effectiveness of
Trevelyan EG, et al. Acupunct Med 2015;33:42–50. doi:10.1136/acupmed-2014-010668
Downloaded from http://aim.bmj.com/ on June 26, 2015 - Published by group.bmj.com
Original paper these treatments remains unclear, with gabapentin demonstrating a trend towards short-term analgesic efficacy and amitriptyline being ineffective.13 Acupuncture has been shown to be effective in the treatment of chronic pain conditions14 but has not been well documented for treating PLP.15 The style of acupuncture and point choice varies widely in the literature.16 Three main consensus approaches are recognised in health research: the Delphi method, nominal group technique and consensus development conference.17 The Delphi technique has the advantage of not requiring face-to-face contact, so facilitating input from a wider group of participants.18 It is well suited to research in which there is incomplete knowledge about a problem or phenomenon and works well when the goal of research is to improve understanding.19 20 The Delphi technique was used in this study to gain agreement on acupuncture principles and to develop a protocol for the treatment of PLP which could be used in future trials and clinical practice. METHODS As a broad understanding of views on treatment was sought, participants both with and without previous experience in treating PLP were included in the study and two parallel surveys were run ( past experience of treating PLP (TPLP) and no prior experience of treating PLP (NTPLP)). A classical Delphi approach using an open first round to facilitate the generation of ideas21 was taken and delivered online. The study was approved by London South Bank University Research Ethics Committee in September 2013, piloted in October 2013, commenced in November 2013 and completed in March 2014. Recruitment
Professional acupuncture associations (British Acupuncture Council, Association of Traditional Chinese Medicine and Acupuncture Association of Chartered Physiotherapists) and universities teaching acupuncture were provided with information about the study and asked to forward information to members/past students. Any participant who contacted the researcher about the study was provided with information. An email sent back by the participant was taken as consent to participate. Convenience and snowball sampling was used to capture as many participants as possible with past experience of treating PLP. Inclusion criteria included: completion of recognised training in acupuncture, registered with a professional body, at least 3 years clinical experience, and the ability to communicate in English. With Delphi studies it is recommended that, for a homogeneous sample, a small sample size is appropriate, such as 10–1520 or 8–12 participants,21 and the study aimed to recruit approximately this number in each group.
Trevelyan EG, et al. Acupunct Med 2015;33:42–50. doi:10.1136/acupmed-2014-010668
Procedure
The study was quasi-anonymous (the principal researcher (ET) knew which response came from which participant but participants did not). An a priori criterion of three rounds of Delphi was set. A fourth anonymous round was included involving rating and commenting on the finalised protocol. Participants were asked to respond to each round within 7–10 days and each round closed after 2 weeks. Subsequent rounds were sent out 2 weeks after closure of the previous round. All questionnaires were developed using the Bristol Online Survey (http://www.survey.bris.ac.uk). Round 1 questionnaire consisted of two hypothetical case studies and 12 open-ended questions per case. Rounds 2 and 3 included statements generated from analysis of round 1. A ‘no comment’ option was provided if participants did not feel qualified to rank a statement. Statements were ranked on a 6-point Likert scale (from strongly disagree to strongly agree). Round 3 also provided additional information: response from the last round, median and IQR. To minimise participant fatigue, questions for which ≥50% of the ranked statements had met consensus in round 2 were not included in round 3 unless agreement had not been met. Analysis of data
Qualitative data were analysed using NVIVO 10 and quantitative data using SPSS V.21. In round 1 qualitative content analysis was used, using thematic criteria.22 Raw data were condensed, and grouped and condensed statements which only appeared once were excluded from round 2. Two researchers (ET and NR) discussed and reviewed the grouped statements to ensure meaning was not lost or biased through researcher interpretation. A consistency check of coding was applied by testing intra-rater reliability 10–14 days after initial coding (ET). Inter-rater reliability was checked through a second coder (NR) who coded a portion of the data. In subsequent rounds an a priori criterion for defining consensus and agreement was set. A group median of 5–6 was considered to mean ‘agree’ and an IQR ≤1.75 was considered indicative of consensus.23 Stability of results was assessed using a Wilcoxon matched pairs signed rank test. The results were deemed stable when there was no significant difference between items.23 A p value ≤0.05 was used in this study. To maximise validity, SD was recorded to demonstrate convergence of results. Round 3 NTPLP and TPLP results were compared to allow for comparison and triangulation between groups. RESULTS Figure 1 shows participant flow throughout the Delphi process. A total of 37 practitioners initially expressed interest in participating; 23 completed round 1 (the
43
Downloaded from http://aim.bmj.com/ on June 26, 2015 - Published by group.bmj.com
Original paper
Figure 1 Flow chart of participants through the study. TPLP, practitioners with past experience of treating phantom limb pain; NTPLP, practitioners with no past experience of treating phantom limb pain.
TPLP group only managed to recruit seven participants), 19 completed both rounds 2 and 3 (12 acupuncturists, 6 physiotherapists practising acupuncture, 1 acupuncturist and physiotherapist) and 17 rated the final protocol. The reason for attrition by the 14 practitioners who did not complete round 1 was sought. A total of 12 responded with 7 reporting lack of time. Table 1 shows the demographics of the participants. All participants had completed acupuncture training in the UK; most practised a combination of Traditional Chinese Medicine (TCM) and 5 Element acupuncture. In the TPLP group, six practised TCM±other acupuncture styles and, in the NTPLP group, 12 practised TCM ±other acupuncture styles. Those who did not practise TCM practised Western medical acupuncture (n=5). In the TPLP group, six were acupuncturists±physiotherapists and one was a physiotherapist. In the NTPLP group, eight were acupuncturists and eight were physiotherapists. Figure 2 provides data on the number of statements included in each round and the number of statements meeting consensus throughout the rounds. In round 1, 619 NTPLP statements and 292 TPLP statements were generated which were condensed down to 204 and 135 statements, respectively. Of the condensed statements, 96 were omitted in the NTPLP group as they did not meet the threshold for inclusion in round 2 (ie, only appeared once) and, in the TPLP group,
44
59 were omitted for the same reason. Of the statements included in round 2, 53% of NTPLP statements and 62% of TPLP statements met consensus and, in round 3, 45% of NTPLP statements and 44% of TPLP statements met consensus. The ‘no comment’ option was selected
