NCT05811533

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

March 31, 2023

Last Update Submit

July 18, 2023

Conditions

Keywords

spencer Muscle energy techniquepost facilitationpainrange of motion

Outcome Measures

Primary Outcomes (3)

  • (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

  • 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

  • SPADI (Shoulder Pain and Disability Index)

    The shoulder pain and disability index (SPADI) is also a reliable and valid clinimetric (Cronbach-α\>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

Study Arms (2)

Spencer's MET with conventional therapy

EXPERIMENTAL

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

Other: Spencer's MET with conventional therapy

Post-Facilitation Stretch with conventional therapy

EXPERIMENTAL

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.

Other: Post-Facilitation Stretch with conventional therapy

Interventions

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

Spencer's MET 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

Post-Facilitation Stretch with conventional therapy

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

BursitisPain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 13, 2023

Study Start

April 1, 2023

Primary Completion

July 10, 2023

Study Completion

July 10, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations