Physiotherapy in management of mechanical shoulder pain
| ISRCTN | ISRCTN30604244 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30604244 |
| Secondary identifying numbers | CEIM/HU/2015/19 |
- Submission date
- 07/06/2016
- Registration date
- 29/06/2016
- Last edited
- 30/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims
Shoulder pain is a very common problem, which is often a complication of a disorder affecting the muscles in the shoulders. Treatment of long-term (chronic) should pain often involves physical therapy, using involving moving the shoulder joint around (manual therapy) and practicing exercises. Dry needling is a technique often used for pain management. It involves using either solid filiform needles (acupuncture needles) or hollow-core hypodermic needles to stimulate certain trigger points (myofacial trigger points) in the muscles to relieve pain. The aim of this study is to investigate the effectiveness of dry needling combined with manual therapy and therapeutic exercises in relieving pain and improving function in patients with chronic shoulder pain.
Who can participate?
Adults with long-term shoulder pain who have sensitive myofacial trigger points in their shoulder muscles.
What does the study involve?
Participants are randomly allocated to one of two groups who attend six study visits over six weeks. In the first study visit, patients either have dry needling, in which trigger points in their shoulders being treated with a filiform needle which is introduced through the skin into the muscle for 15 seconds, or sham needling, in which a sham (placebo) needle is used to prick the skin but not reach the muscle in the trigger points. For the remaining sessions, participants in both groups complete 75 minutes of manual therapy with a physiotherapist as well as practicing shoulder movement exercises twice a week for six weeks. Participants in both groups have their pain levels and shoulder function tested at the start of the study and then after one week, three months and six months.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.
Where is the study run from?
Alcalá Clíinical University (Spain)
When is the study starting and how long is it expected to run for?
September 2015 to February 2017
Who is funding the study?
Alcalá University (Spain)
Who is the main contact?
Dr Daniel Pecos-Martin
Contact information
Scientific
Alcalá University
Faculty of Physiotherapy. Pain and Physiotherapy Group
Crta. Madrid-Barcelona, km 33.600
Alcalá de Henares
28878
Spain
Study information
| Study design | Single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Dry needling in a manual therapy protocol and therapeutic exercises for patients with chronic shoulder pain of unspecified origin |
| Study hypothesis | The application of deep dry needling in a manual therapy protocol and therapeutic exercises produces a significant improvement in the chronic shoulder pain of unspecified origin. |
| Ethics approval(s) | Ethical Comite of Alcalá University, 20/12/2015, ref: CEIM/HU/2015/19 |
| Condition | Shoulder pain of unspecified origin |
| Intervention | Participants are randomised to one of two treatment groups using Epidat 3.1 software. Intervention group: Participants attend six study visits over a period of six weeks. In the first session, participants undergo Deep Dry Needling of the hyperalgesic points of infraspinatus muscle, upper trapezius, middle deltoid and subscapularis. This involves each muscle being treated with a filiform needle that will be introduced through the skin in order to eliminate pain. The technique is applied for 15 seconds on each muscle. For the remaining sessions, participants undergo 75 minutes of manual therapy, which involves practicing joint mobilization techniques in the glenohumeral joint, mobilization of the scapula, compression techniques and stretching of muscles. Control group: Participants attend six study visits over a period of six weeks. In the first session, participants undergo Sham Dry Needling of the hyperalgesic points of infraspinatus muscle, upper trapezius, middle deltoid and subscapularis. his involves each muscle being treated with a placebo needle, i.e. the patient will feel pricking of the skin but the needle does not reach the muscle. For the remaining sessions, participants undergo 75 minutes of manual therapy, which involves practicing joint mobilization techniques in the glenohumeral joint, mobilization of the scapula, compression techniques and stretching of muscles. Participants in both groups are asked to perform domiciliary Therapeutic Exercises twice a week, on non-consecutive days. These exercises involve active movement exercises without pain and stretching of muscles |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Functionality and quality of life is measured using the disabilities of the arm, shoulder and hand (DASH) scale at baseline, 1 week, 3 and 6 months 2. Pain is measured using a visual analogue scale (VAS) at baseline, 1 week, 3 and 6 months |
| Secondary outcome measures | 1. Range of Motion (ROM) is measured using a goniometer at baseline, 1 week, 3 and 6 months 2. Medication intake is measured using interview at baseline, 1 week, 3 and 6 months 3. Pressure Pain Threshold (PPT) is measures using a algometer baseline, 1 week, 3 and 6 months |
| Overall study start date | 16/09/2015 |
| Overall study end date | 15/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 36 |
| Participant inclusion criteria | 1. Aged 18 to 65 years 2. Chronic Shoulder Pain of Unspecified Origin (tendinitis, impingement syndrome, shoulder pain/painful shoulder) with a minimum of 3 months of pathology 3. Presence of active MTrPs or areas of hypersensitivity (upper trapezius, infraspinatus, middle deltoids and subscapularis) 4. Those who have Myofascial trigger points (MTrPs) that reproduce their pain in one or more muscles 5. Provision of informed consent |
| Participant exclusion criteria | 1. Participants who have undergone surgery on the shoulder, who suffered rotator cuff tear, adhesive capsulitis, calcific tendonitis, dislocation of the humeral head, shoulder instability, whiplash, cervical radiculopathy and previous interventions with corticosteroid injections 2. Associated pathologies, such as fear of needles, diabetes, osteoarthritis and fibromyalgia syndrome 3. Have received dry needling in the last six months 4. Receiving other physiotherapy treatment 5. Pregnancy |
| Recruitment start date | 16/09/2016 |
| Recruitment end date | 16/02/2017 |
Locations
Countries of recruitment
- Spain
Study participating centre
Crta Madrid - Barcelona, km 33. 600
Alcalá de Henares
28871
Spain
Sponsor information
University/education
Physical Therapy Department
Campus Externo
Crta. Madrid-Barcelona, km. 33,600
Alcalá de Henares
28874
Spain
| Website | www.uah.es |
|---|---|
"ROR" |
https://ror.org/04pmn0e78 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 15/02/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 18/09/2017 | 30/11/2020 | Yes | No |
Editorial Notes
30/11/2020: Publication reference and total final enrolment added.
07/09/2016: The overall trial end date has been updated from 15/02/2017 to 15/06/2017 and the recruitment dates have been updated from 15/06/2016 - 15/06/2017 to 16/09/2016 - 16/02/2017.
