Real Versus Sham Manual Therapy for RCRSP

Shoulder Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440046
• Other study ID #: 2/111/729
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: April 18, 2021

Study information

• Verified date: June 2021
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 18, 2021
• Est. primary completion date: April 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• Manual therapy thoracic spine
Manual therapy mobilization directed to the costovertebral joint.
• Manual therapy glenohumeral joint
Manual therapy mobilization directed to the glenohumeral joint.
• Sham thoracic manual therapy
Sham manual therapy directed to the costovertebral joint.
• Sham glenohumeral manual therapy
Sham manual therapy directed to the glenohumeral joint.
• Therapeutic exercise
Therapeutic exercise program consisting on isometric exercise with progressive load.

Locations

Country	Name	City	State
Spain	Ruben Fernandez-Matias	Alcalá De Henares

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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