Background: Adhesive capsulitis (AC) is a common condition that includes shoulder pain and limited movement. Despite more than 100 years of AC treatment, the most efficacious treatment remains unclear. The aim of this study was to evaluate the feasibility of a randomized controlled trial (RCT) using...
Background: Adhesive capsulitis (AC) is a common condition that includes shoulder pain and limited movement. Despite more than 100 years of AC treatment, the most efficacious treatment remains unclear. The aim of this study was to evaluate the feasibility of a randomized controlled trial (RCT) using acupuncture for AC. Methods: Thirty participants with AC were randomly assigned to acupuncture (A) or sham acupuncture (SA) groups. The participants received 15 acupuncture sessions over 6 weeks, and follow-up occurred for an additional 4 weeks thereafter. The primary clinical outcome was the numeric rating scale (NRS) for shoulder pain 6 weeks from the baseline. Secondary outcomes included range of motion (ROM) in the shoulder, the shoulder pain and disability index (SPADI), the EuroQol-5 dimensions (EQ-5D), the Pittsburgh sleep quality index (PSQI), and the patient global impression of change (PGIC). Results: Thirty participants were enrolled out of 37 screened individuals. Recruitment was conducted between August 2014 until May 2015. A total of 28 participants (93%) completed the 6-week intervention, and 26 participants (87%) completed the study. NRS, ROM, SPADI, EQ-5D, PSQI, and PGIC scores improved in both the experimental group and the sham group after 6 weeks, but the difference between the groups was not statistically significant. Adverse events were reported by 12 participants, although these events were not associated with acupuncture. Conclusion: A future RCT for AC may be feasible with some modifications to the recruitment plan and the secondary outcome measurement methods.
Background: Adhesive capsulitis (AC) is a common condition that includes shoulder pain and limited movement. Despite more than 100 years of AC treatment, the most efficacious treatment remains unclear. The aim of this study was to evaluate the feasibility of a randomized controlled trial (RCT) using acupuncture for AC. Methods: Thirty participants with AC were randomly assigned to acupuncture (A) or sham acupuncture (SA) groups. The participants received 15 acupuncture sessions over 6 weeks, and follow-up occurred for an additional 4 weeks thereafter. The primary clinical outcome was the numeric rating scale (NRS) for shoulder pain 6 weeks from the baseline. Secondary outcomes included range of motion (ROM) in the shoulder, the shoulder pain and disability index (SPADI), the EuroQol-5 dimensions (EQ-5D), the Pittsburgh sleep quality index (PSQI), and the patient global impression of change (PGIC). Results: Thirty participants were enrolled out of 37 screened individuals. Recruitment was conducted between August 2014 until May 2015. A total of 28 participants (93%) completed the 6-week intervention, and 26 participants (87%) completed the study. NRS, ROM, SPADI, EQ-5D, PSQI, and PGIC scores improved in both the experimental group and the sham group after 6 weeks, but the difference between the groups was not statistically significant. Adverse events were reported by 12 participants, although these events were not associated with acupuncture. Conclusion: A future RCT for AC may be feasible with some modifications to the recruitment plan and the secondary outcome measurement methods.
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제안 방법
All adverse events (AEs) were recorded by practitioners, using an AE report form. The following data were recorded: the date of occurrence and disappearance, severity and outcomes of AEs, measures taken in relation to the study and their relationships with the treatment, medicines or treatments other than the study treatment, and details of any treatment for AEs.
For sociodemographic characteristics, numeric variables were presented as means and standard deviations, while categorical variables were presented as frequencies and percentages. Analyses were conducted on both a full analysis set (FAS) and a per-protocol set (PPS). A FAS was used to describe the set that was as complete as possible and as close as possible to the intention-to-treat (ITT) ideal of including all randomized participants.
The Pittsburgh sleep quality index (PSQI) assessed sleep quality and identified sleep disturbances [15]. Seven items, including subjective sleep quality, sleep latency, sleep time, habitual sleep efficiency, sleep disturbance, sleeping pills, and daytime dysfunction, were measured at baseline, Week 7, and Week 11.
All adverse events (AEs) were recorded by practitioners, using an AE report form. The following data were recorded: the date of occurrence and disappearance, severity and outcomes of AEs, measures taken in relation to the study and their relationships with the treatment, medicines or treatments other than the study treatment, and details of any treatment for AEs. The severity of AEs was classified into 3 grades (1 = mild, 2 = moderate, and 3 = severe).
All participants provided written informed consent. The information included the purpose of the study, participation period, number of participants, study procedure, benefits from participation, anticipated harms, withdrawal of consent to participation, rules to follow during the study period, compensation and treatment in case of damage related to research, confidentiality of personal information, reasons for participation being discontinued during the study, and the name and contact information of the researcher. All care was taken to protect the privacy of participants.
The results from this study suggest that a future RCT for AC may be possible, with some modifications to the recruitment plan and the secondary outcome measurement methods.
This study was a 2-arm, randomized, controlled, and parallel-designed pilot trial. The study period was 10 weeks, which included a 6-week intervention procedure and a 4-week follow-up examination. The trial design is shown as a flow diagram in Fig.
This study was a 2-arm, randomized, controlled, and parallel-designed pilot trial. The study period was 10 weeks, which included a 6-week intervention procedure and a 4-week follow-up examination.
A digital goniometer (iGaging, San Clemente, CA, USA) was used to assess range of motion (ROM) in the shoulder joint, using flexion, abduction, internal rotation, and external rotation movements. To reduce measurement errors, prior to the start of the study, the ROM measurers were trained via a one-day course. The measurements were always performed in the same order (flexion, abduction, internal rotation, and external rotation).
대상 데이터
Participants in both groups received 15 intervention sessions for 6 weeks. In the A group, treatment points were LI10 (Susamni), LI15 (Gyeonu), LI16 (Geogol), LU2 (Unmun), LU5 (Cheoktaek), SI9 (Gyeonjeong), SI11 (Cheonjong), TE14 (Gyeollyo), TE15 (Cheollyo), and SP19 (Hyunghyang) on the affected side. The acupoints were chosen based on the theory of meridians in traditional Oriental medicine [7,9,10].
Participants were recruited from Daejeon Oriental Hospital of Daejeon University, Daejeon, Korea. When a participant contacted the clinical trial center by telephone or by e-mail through the recruitment advertisement, the clinical research coordinator scheduled the participant’s visit to the clinical trial center.
In the SA group, non-penetrating Park sham placebo devices were used[11]. The treatment points were LI16, SI9, SI11, TE14, TE15, BL12 (Pungmun), BL13 (Pyesu), BL14 (Gworeumsu), BL15 (Simsu), and BL16 (Doksu) on the affected side [7,9,10]. To maintain blinding, acupuncture points in the back (BL12, BL13, BL14, BL15, and BL16) were used instead of LI10, LI15, LU2, LU5, and SP19, which were visible to participants during the procedure.
Recruitment was conducted from August 2014 to May 2015. Thirty participants were selected from 37 screened individuals (Fig. 1). In the A group, 218 acupuncture sessions (97%) were administered during the study period.
This study was supported by the Korea Institute of Oriental Medicine (K14011, K17122, and K18121). The funder had no role in the design of the study; the collection, analysis, and interpretation of data; the composition of the manuscript; or the decision to submit the manuscript for publication.
The treatment points were LI16, SI9, SI11, TE14, TE15, BL12 (Pungmun), BL13 (Pyesu), BL14 (Gworeumsu), BL15 (Simsu), and BL16 (Doksu) on the affected side [7,9,10]. To maintain blinding, acupuncture points in the back (BL12, BL13, BL14, BL15, and BL16) were used instead of LI10, LI15, LU2, LU5, and SP19, which were visible to participants during the procedure. The devices remained in position for 20 minutes without inducing a de qi sensation [7].
데이터처리
80. Additionally, a repeated measures analysis of variance (RM ANOVA) was performed to assess a potential interaction between timepoint and group. Other outcomes (ROM, SPADI, EQ-5D, and PSQI) were similarly analyzed.
Between-group comparisons were analyzed using analysis of covariance (ANCOVA) with the evaluation values of each outcome as a dependent variable, baseline value as a covariate, and group as a fixed factor. The analysis was performed with an α-value of 0.
Other outcomes (ROM, SPADI, EQ-5D, and PSQI) were similarly analyzed. PGIC was analyzed using analysis of variance (ANOVA), since PGIC had no baseline value and was not included in the RM ANOVA. The blind test was analyzed using a Fisher’s exact test.
The blind test was analyzed using a Fisher’s exact test. Within-group comparisons were analyzed with either paired t test or Wilcoxon signed-rank test. For sociodemographic characteristics, numeric variables were presented as means and standard deviations, while categorical variables were presented as frequencies and percentages.
이론/모형
The blind test was analyzed using a Fisher’s exact test.
To evaluate the success of blinding, index values were calculated (not initially planned) using the blinding index (BI) that was reported in 2004 [26]. After the first intervention, the BI value of the A group was 0.
성능/효과
After the last intervention, 9 of 14 participants in the A group (64%) guessed that they belonged to the A group, 1 participant (7%) guessed that they belonged to the SA group, and 4 participants answered “don’t know” (29%).
In the SA group, significant improvements occurred on the NRS (Weeks 4, 7, and 11), ROM (flexion at Week 11; abduction at Weeks 4, 7, and 11; and external rotation at Week 7), EQ-5D (Week 11), SPADI (pain and total, at Weeks 7 and 11; disability at Week 7), and PSQI (Week 11) compared to baseline (Tables 2–5).
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