search
Back to results

Real Versus Sham Manual Therapy for RCRSP

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual therapy thoracic spine
Manual therapy glenohumeral joint
Sham thoracic manual therapy
Sham glenohumeral manual therapy
Therapeutic exercise
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • unilateral shoulder pain of non-traumatic origing lasting more than three months.
  • Pain evoked with active shoulder movements.
  • Pain and weakness evoked with manual muscle strength tests for abduction and/or external rotation.
  • Minimal or no rest pain (less than 3 points in a numeric pain rating scale).

Exclusion Criteria:

  • Other shoulder pathologies than RCRSP.
  • Systemic diseases.
  • Neural symptoms.
  • Neck pain.
  • Radiculopathy.
  • To have been treated for shoulder pain in the last three months.

Sites / Locations

  • Ruben Fernandez-Matias

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Sham Comparator

Arm Label

Real manual therapy

Sham thoracic manual therapy

Sham manual therapy

Arm Description

Real manual therapy directed to the thoracic spine and glenohumeral joint added to a therapeutic exercise program

Sham manual therapy directed to the thoracic spine with real manual therapy directed to the glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group

Sham manual therapy directed to the thoracic spine and glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group

Outcomes

Primary Outcome Measures

Shoulder Pain and Disability Index (SPADI)
The SPADI points from 0 (no disability) to 130 (maximum degree of disability)

Secondary Outcome Measures

Pain intensity measured with a visual analogue scale
10-cm scale where 0 is no pain and 10 is the worst pain imaginable
Pain-free range of movement of the shoulder
Flexion, extension, abduction, internal rotation and external rotation measured with a two-arm goniometer

Full Information

First Posted
June 15, 2020
Last Updated
June 28, 2021
Sponsor
University of Alcala
search

1. Study Identification

Unique Protocol Identification Number
NCT04440046
Brief Title
Real Versus Sham Manual Therapy for RCRSP
Official Title
Real Versus Sham Manual Therapy in Addition to Therapeutic Exercise in the Treatment of Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
April 18, 2021 (Actual)
Study Completion Date
April 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A convenience sample of subjects with RCRSP recruited through announcements at the Benemerita Universidad Autonoma de Puebla will be treated with an exercise program with sham or real manual therapy for 5 weeks. The hypothesis of the present study is that the addition of manual therapy to a therapeutic exercise program produces better benefits in comparison to the same exercise program with sham manual therapy procedures in the management of patients with RCRSP.
Detailed Description
The objective of this study is to demonstrate that the combination of manual therapy and therapeutic exercise achieves better results in the management of the patient with shoulder pain. For this, manual therapy techniques in the thoracic region and in the shoulder together with a therapeutic exercise program will be applied. The investigators will compare this intervention protocol with placebo manual therapy techniques and the same therapeutic exercise protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Real manual therapy
Arm Type
Experimental
Arm Description
Real manual therapy directed to the thoracic spine and glenohumeral joint added to a therapeutic exercise program
Arm Title
Sham thoracic manual therapy
Arm Type
Sham Comparator
Arm Description
Sham manual therapy directed to the thoracic spine with real manual therapy directed to the glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group
Arm Title
Sham manual therapy
Arm Type
Sham Comparator
Arm Description
Sham manual therapy directed to the thoracic spine and glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group
Intervention Type
Other
Intervention Name(s)
Manual therapy thoracic spine
Intervention Description
Manual therapy mobilization directed to the costovertebral joint.
Intervention Type
Other
Intervention Name(s)
Manual therapy glenohumeral joint
Intervention Description
Manual therapy mobilization directed to the glenohumeral joint.
Intervention Type
Other
Intervention Name(s)
Sham thoracic manual therapy
Intervention Description
Sham manual therapy directed to the costovertebral joint.
Intervention Type
Other
Intervention Name(s)
Sham glenohumeral manual therapy
Intervention Description
Sham manual therapy directed to the glenohumeral joint.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise
Intervention Description
Therapeutic exercise program consisting on isometric exercise with progressive load.
Primary Outcome Measure Information:
Title
Shoulder Pain and Disability Index (SPADI)
Description
The SPADI points from 0 (no disability) to 130 (maximum degree of disability)
Time Frame
Change from Baseline at 17- week
Secondary Outcome Measure Information:
Title
Pain intensity measured with a visual analogue scale
Description
10-cm scale where 0 is no pain and 10 is the worst pain imaginable
Time Frame
Change from Baseline at 17-week
Title
Pain-free range of movement of the shoulder
Description
Flexion, extension, abduction, internal rotation and external rotation measured with a two-arm goniometer
Time Frame
Change from Baseline at 17-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unilateral shoulder pain of non-traumatic origing lasting more than three months. Pain evoked with active shoulder movements. Pain and weakness evoked with manual muscle strength tests for abduction and/or external rotation. Minimal or no rest pain (less than 3 points in a numeric pain rating scale). Exclusion Criteria: Other shoulder pathologies than RCRSP. Systemic diseases. Neural symptoms. Neck pain. Radiculopathy. To have been treated for shoulder pain in the last three months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Pecos-Martin, PhD
Organizational Affiliation
University of Alcala
Official's Role
Study Director
Facility Information:
Facility Name
Ruben Fernandez-Matias
City
Alcalá De Henares
ZIP/Postal Code
28805
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Real Versus Sham Manual Therapy for RCRSP

We'll reach out to this number within 24 hrs