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Dry Needling and Exercises in Shoulder Pain

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
exercise program
TrP-DN
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring dry needling, trigger point, eccentric exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Unilateral non-traumatic shoulder pain
  • Shoulder pain from at least 3 months
  • Shoulder pain of more than 4 points on a NPRS

Exclusion Criteria:

  • bilateral shoulder symptoms
  • younger than 18 or older than 65 years
  • history of shoulder fractures or dislocation
  • cervical radiculopathy
  • previous interventions with steroid injections
  • fibromyalgia syndrome
  • previous history of shoulder or neck surgery
  • any type of intervention for the neck-shoulder area during the previous year

Sites / Locations

  • César Fernández-de-las-Peñas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks. In addition, within the second and fourth sessions, they will receive TrP-DN over active TrPs in the shoulder muscles

Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks.

Outcomes

Primary Outcome Measures

Changes in disability between baseline and follow-up periods
The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain

Secondary Outcome Measures

Changes in shoulder pain between baseline and follow-up periods
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain and the worst level of pain experienced in the preceding week in the shoulder area.

Full Information

First Posted
January 11, 2015
Last Updated
March 14, 2016
Sponsor
Universidad Rey Juan Carlos
Collaborators
Hospital General Universitario Gregorio Marañon
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1. Study Identification

Unique Protocol Identification Number
NCT02338908
Brief Title
Dry Needling and Exercises in Shoulder Pain
Official Title
Effectiveness of Dry Needling and Eccentric Exercises in Unspecific Shoulder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
Collaborators
Hospital General Universitario Gregorio Marañon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Shoulder pain is highly prevalent in the society. The role of muscle tissues in this pathology has received increasing interest. Some studies have proposed the role of myofascial trigger points in this population. The purpose of the current clinical trial is to compare the effects of physiotherapy treatment consisting of an eccentric exercise protocol versus the same physical therapy program plus the addition of trigger point dry needling (TrP-DN) on pain and function in patients suffering from unspecific shoulder pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
dry needling, trigger point, eccentric exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks. In addition, within the second and fourth sessions, they will receive TrP-DN over active TrPs in the shoulder muscles
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks.
Intervention Type
Other
Intervention Name(s)
exercise program
Intervention Description
Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks.
Intervention Type
Other
Intervention Name(s)
TrP-DN
Intervention Description
In addition, within the second and fourth sessions, they will receive TrP-DN over active TrPs in the shoulder muscles
Primary Outcome Measure Information:
Title
Changes in disability between baseline and follow-up periods
Description
The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain
Time Frame
Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention
Secondary Outcome Measure Information:
Title
Changes in shoulder pain between baseline and follow-up periods
Description
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain and the worst level of pain experienced in the preceding week in the shoulder area.
Time Frame
Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral non-traumatic shoulder pain Shoulder pain from at least 3 months Shoulder pain of more than 4 points on a NPRS Exclusion Criteria: bilateral shoulder symptoms younger than 18 or older than 65 years history of shoulder fractures or dislocation cervical radiculopathy previous interventions with steroid injections fibromyalgia syndrome previous history of shoulder or neck surgery any type of intervention for the neck-shoulder area during the previous year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
César Fernández-de-las-Peñas, PT, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
César Fernández-de-las-Peñas
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27720812
Citation
Arias-Buria JL, Fernandez-de-Las-Penas C, Palacios-Cena M, Koppenhaver SL, Salom-Moreno J. Exercises and Dry Needling for Subacromial Pain Syndrome: A Randomized Parallel-Group Trial. J Pain. 2017 Jan;18(1):11-18. doi: 10.1016/j.jpain.2016.08.013. Epub 2016 Oct 5.
Results Reference
derived

Learn more about this trial

Dry Needling and Exercises in Shoulder Pain

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