Acupuncture and rehabilitation in the painful shoulder: a blinded randomised multicentre study

Not Applicable

Completed

• Conditions: Musculoskeletal Diseases; Shoulder pain

• Registration Number: ISRCTN28687220
• Lead Sponsor: Foundation Progress and Health (Council of Andalusian Health Services) (Spain)

Brief Summary

2005 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/16225693 2008 Results article in http://www.ncbi.nlm.nih.gov/pubmed/18403402

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-04
• Study Completion: 2007-02-28
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 465

Inclusion Criteria

Patients referred to the Rehabilitation Services of health centres participating in the study and belonging to the Public Health System (Andalusian Public Health System and Murcia Public Health System). Patients presenting chronic symptoms of painful shoulder with a diagnosis of supraspinal tendinitis or subacromial bursitis. The treatment proposed is physiotherapy combined with acupuncture or with transcutaneous stimulation (TENS) - placebo. Patients will be informed of the study design and of the techniques to be employed, as well as of the possible risks (infection, lipothymia, hematomas). They will be informed that they are free to conclude their participation in the study at any time, and will suffer no kind of penalty for doing so, nor will they lose any of the benefits to which they are entitled.

Selection criteria:
Approval by the Ethics Committee of the reference hospital.

Criteria for inclusion:
1. Patients with a clinical diagnosis of subacromial syndromes (supraspinal tendinitis or subacromial bursitis) with an evolution period greater than 3 months
2. Prior radiograph (normal)
3. Informed consent
4. Unilateral complaint

The sample size was determined for a significance level of 0.05 and a power of 0.80, with a final average score of 70 on Constant?s Functional Evaluation Scale for the Shoulder for the experimental group (standard deviation = 17) and of 65 for the control group (standard deviation = 18), using a two-tailed test. According to data obtained from earlier studies, 188 patients are required for the experimental group and 199 for the control group. Assuming a drop-out rate of 20%, the final sample size was set at 226 patients for the experimental group and 239 for the control group.

Exclusion Criteria

1. Surgery
2. Luxations or fractures in the proximity of the shoulder
3. Other significant traumas
4. Direct or indirect (in traction) observed during anamnesis and clearly related to the onset of the episode
5. Hypocoagulates
6. Generalised disorders of the muscular-skeletal system
7. Neurological disorders
8. Vscular trophic disorders in the lower limbs
9. Lymphoedema

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Constant-Murley score.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Changes in the intensity of diurnal pain according to visual analogic scale<br> 2. Changes in the intensity of night-time pain according to visual analogic scale<br> 3. Dose of non-steroidal anti-inflammatory drugs (NSAIDs) taken during the study<br> 4. Scale of credibility of the treatment<br>