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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04440046
Enrollment
45
Registered
2020-06-19
Start date
2020-12-15
Completion date
2021-04-18
Last updated
2021-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

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.

Interventions

OTHERManual therapy thoracic spine

Manual therapy mobilization directed to the costovertebral joint.

OTHERManual therapy glenohumeral joint

Manual therapy mobilization directed to the glenohumeral joint.

OTHERSham thoracic manual therapy

Sham manual therapy directed to the costovertebral joint.

OTHERSham glenohumeral manual therapy

Sham manual therapy directed to the glenohumeral joint.

OTHERTherapeutic exercise

Therapeutic exercise program consisting on isometric exercise with progressive load.

Sponsors

University of Alcala
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Shoulder Pain and Disability Index (SPADI)Change from Baseline at 17- weekThe SPADI points from 0 (no disability) to 130 (maximum degree of disability)

Secondary

MeasureTime frameDescription
Pain intensity measured with a visual analogue scaleChange from Baseline at 17-week10-cm scale where 0 is no pain and 10 is the worst pain imaginable
Pain-free range of movement of the shoulderChange from Baseline at 17-weekFlexion, extension, abduction, internal rotation and external rotation measured with a two-arm goniometer

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026