Real Versus Sham Manual Therapy for RCRSP

Real Versus Sham Manual Therapy in Addition to Therapeutic Exercise in the Treatment of Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Other: Manual therapy thoracic spine; Other: Manual therapy glenohumeral joint; Other: Therapeutic exercise; Other: Sham thoracic manual therapy; Other: Sham glenohumeral manual therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alcalá De Henares, Spain, 28805
    • Rubén Fernández-Matías

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real manual therapy; Real manual therapy directed to the thoracic spine and glenohumeral joint added to a therapeutic exercise program	Other: Manual therapy thoracic spine; Manual therapy mobilization directed to the costovertebral joint.; Other: Manual therapy glenohumeral joint; Manual therapy mobilization directed to the glenohumeral joint.; Other: Therapeutic exercise; Therapeutic exercise program consisting on isometric exercise with progressive load.
Sham Comparator: Sham thoracic manual therapy; 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	Other: Manual therapy glenohumeral joint; Manual therapy mobilization directed to the glenohumeral joint.; Other: Therapeutic exercise; Therapeutic exercise program consisting on isometric exercise with progressive load.; Other: Sham thoracic manual therapy; Sham manual therapy directed to the costovertebral joint.
Sham Comparator: Sham manual therapy; 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	Other: Therapeutic exercise; Therapeutic exercise program consisting on isometric exercise with progressive load.; Other: Sham thoracic manual therapy; Sham manual therapy directed to the costovertebral joint.; Other: Sham glenohumeral manual therapy; Sham manual therapy directed to the glenohumeral joint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain and Disability Index (SPADI)	The SPADI points from 0 (no disability) to 130 (maximum degree of disability)	Change from Baseline at 17- week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity measured with a visual analogue scale	10-cm scale where 0 is no pain and 10 is the worst pain imaginable	Change from Baseline at 17-week
Pain-free range of movement of the shoulder	Flexion, extension, abduction, internal rotation and external rotation measured with a two-arm goniometer	Change from Baseline at 17-week

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Study Director: Daniel Pecos-Martin, PhD, University of Alcala

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): April 18, 2021
• Study Completion (Actual): April 18, 2021

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 2/111/729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No