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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05811533
Other study ID # REC/MS-PT/01496 Neelam
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date July 10, 2023

Study information

Verified date July 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adhesive capsulitis is one of the most common problems of the upper limb. Adhesive capsulitis (AC) and frozen shoulder syndrome (FSS) are two terms that have been used to describe a painful and stiff shoulder. Conservative treatment includes transcutaneous electrical nerve stimulation (TENS), Ultrasound, LASER, Range of Motion, stretching and strengthening exercises, patient education, and home exercises. Manual therapy includes mobilization, Spencer's Muscle Energy Technique and Mobilization With Movement.


Description:

The American Academy of Orthopedic Surgeons defines this condition as: "A condition of varying severity characterized by the gradual development of global limitation of active and passive shoulder motion where radiographic findings other than osteopenia are absent." Patients with frozen shoulder typically experience insidious shoulder stiffness, severe pain that usually worsens at night, and near-complete loss of passive and active external rotation of the shoulder. Although spencer's Muscle Energy Technique is a very effective technique, still it was rarely used. It is a standardized series of steps of shoulder treatments with broad application in diagnosis, treatment, and prognosis developed by Spencer in 1961 and is a well-known osteopathic manipulative technique that focuses on mobilization of the glenohumeral and scapulothoracic joints. It is an articulatory technique in which passive, smooth, rhythmic motion of the shoulder joint is done by the therapist to stretch contracted muscles, ligaments, and capsule. Most of the force is applied at the end range of motion. This technique increases pain-free Range of Motion by stretching the tissues, enhancing lymphatic flow, and stimulating increased joint circulation. On the other hand, "post-facilitation stretch (PFS)" is a muscle energy technique developed by Dr.Vladimir Janda to lengthen chronically shortened muscles that involves a maximal contraction of the muscle at mid-range with a rapid movement to maximal length followed by a 20-second static stretch. This technique is more aggressive than Post Isometric Relaxation and based on the concept of autogenic inhibition


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 10, 2023
Est. primary completion date July 10, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Patients with primary unilateral adhesive capsulitis - Stage II and III adhesive capsulitis - Patients with limited active and passive Range of Motion of the affected shoulder (globally loss of at least 50% compared to non-involved shoulder in one or more directions) - Patients with controlled diabetes Exclusion Criteria: - Patients with a positive history of trauma, fracture, or surgery of the cervical spine - Corticosteroid injection in the affected shoulder in the preceding 4 weeks. - Malignancy/Avascular Necrosis of shoulder - Post-traumatic shoulder stiffness - Thoracic outlet syndrome/neurological disorder - Patients with cervical radiculopathy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Spencer's MET with conventional therapy
Patients will be asked to lie in a side lying position with the affected shoulder above. The therapist will stabilize the shoulder girdle with the proximal hand and the distal hand provided force into the restrictive barrier of shoulder in 7 different movements. During all the movements, patients will ask to use their muscle energy 20% against the slight resistance offered by the therapist for 3-5 seconds. The patient then asks to relax and exhale after that shoulder joint will move beyond the barrier to achieve the next barrier. After 20 sec of rest, this technique will be repeated 3-5 times
Post-Facilitation Stretch with conventional therapy
Muscle Energy Technique [Post Facilitation Stretch)] for the shoulder joint will be applied with 3 repetitions per set, 1 session per day. Patient will be instructed to perform a full strength contraction of the muscle to be stretch for 10 seconds. The muscle is then allow to fully relax, whereupon a rapid stretch of the affected muscle will be performed and will held in position by the physician for 15 sec. Patient will be asked to relax and whole cycle will be repeated

Locations

Country Name City State
Pakistan Railway General Hospital Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary (Numeric Pain Rating Scale) The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable four weeks
Primary Goniometer A goniometer is a device that measures an angle or permits the rotation of an object to a definite position. To measure the range of motion, doctors, osteopaths, physical therapists, or other health professionals most commonly use a goniometer, which is an instrument that measures angle motion at a joint four weeks
Primary SPADI (Shoulder Pain and Disability Index) The shoulder pain and disability index (SPADI) is also a reliable and valid clinimetric (Cronbach-a>0.90), self-administered questionnaire used by orthopedics and physical therapists for proper assessment of shoulder related pain and disabilities in terms of functional outcomes in patients suffering from different types of the shoulder-related pathologies. It consists of 13 items with two domains; a subscale (5-item) that measures pain, and another subscale (8-item) that assesses disability. Each subscale is added and transformed into a score that ranges from 0 (less shoulder disability) to 100 (more shoulder dysfunction). four weeks
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