Real Versus Sham Manual Therapy for RCRSP

NCT04440046 | Completed

• 1 other identifier: 2/111/729
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain intensity measured with a visual analogue scale

  Change from Baseline at 17-week

• Pain-free range of movement of the shoulder

  Change from Baseline at 17-week

Study Arms (3)

Real manual therapy

EXPERIMENTAL

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

Other: Manual therapy thoracic spine; Other: Manual therapy glenohumeral joint; Other: Therapeutic exercise

Sham thoracic manual therapy

SHAM COMPARATOR

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; Other: Sham thoracic manual therapy; Other: Therapeutic exercise

Sham manual therapy

SHAM COMPARATOR

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: Sham thoracic manual therapy; Other: Sham glenohumeral manual therapy; Other: Therapeutic exercise

Interventions

Manual therapy thoracic spine OTHER

Manual therapy mobilization directed to the costovertebral joint.

Real manual therapy

Manual therapy glenohumeral joint OTHER

Manual therapy mobilization directed to the glenohumeral joint.

Real manual therapy; Sham thoracic manual therapy

Sham thoracic manual therapy OTHER

Sham manual therapy directed to the costovertebral joint.

Sham manual therapy; Sham thoracic manual therapy

Sham glenohumeral manual therapy OTHER

Sham manual therapy directed to the glenohumeral joint.

Sham manual therapy

Therapeutic exercise OTHER

Therapeutic exercise program consisting on isometric exercise with progressive load.

Real manual therapy; Sham manual therapy; Sham thoracic manual therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Ruben Fernandez-Matias

Alcalá de Henares, 28805, Spain

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Daniel Pecos-Martin, PhD

  University of Alcala

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 19, 2020
• Study Start: December 15, 2020
• Primary Completion: April 18, 2021
• Study Completion: April 18, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)