Condition category
Signs and Symptoms
Date applied
07/06/2016
Date assigned
29/06/2016
Last edited
07/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Pecos-Martin

ORCID ID

Contact details

Alcalá University
Faculty of Physiotherapy. Pain and Physiotherapy Group
Crta. Madrid-Barcelona
km 33.600
Alcalá de Henares
28878
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CEIM/HU/2015/19

Study information

Scientific title

Dry needling in a manual therapy protocol and therapeutic exercises for patients with chronic shoulder pain of unspecified origin

Acronym

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

Ethical Comite of Alcalá University, 20/12/2015, ref: CEIM/HU/2015/19

Study design

Single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

16/09/2015

Overall trial end date

15/06/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

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

Trial participating centre

Alcalá Clíinical University
Faculty Physiotherapy Crta Madrid - Barcelona, km 33. 600
Alcalá de Henares
28871
Spain

Sponsor information

Organisation

Alcalá University

Sponsor details

Physical Therapy Department
Campus Externo
Crta. Madrid-Barcelona
km. 33,600
Alcalá de Henares
28874
Spain

Sponsor type

University/education

Website

www.uah.es

Funders

Funder type

University/education

Funder name

Alcalá University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

15/02/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.