NCT06404814

Brief Summary

This study focus on the rehabilitation of patients with frozen shoulder through a manual technique called "Spencer MET".The purpose of this approach is to reduce the pain and improve the ROM and quality of life.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

September 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

May 5, 2024

Last Update Submit

May 5, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scale (VAS):

    It is tool widely used to measure the intensity of pain and discomfort.VAS effectively used in randomized controlled trials for outcome measures,consisting of 10 cm straight line from 0 to 10.0 represents "No pain" and 10 represent "Worst pain". Patients can mark their severity of pain.

    12 Months

  • Goniometer

    Goniometer is instrument used to measure the range of motion of a joint.

    12 months

Study Arms (2)

Transcutaneous electrical nerve stimulation (TENS)

OTHER
Behavioral: Transcutaneous electrical nerve stimulation (TENS)

Muscle Energt Techinique (METs)

EXPERIMENTAL
Diagnostic Test: Muscle Energy Technique

Interventions

(TENS) is a method of pain relief involving the use of a mild electrical current

Transcutaneous electrical nerve stimulation (TENS)

n Spencer's technique, there are seven steps as follows: shoulder extension along with elbow flexion, shoulder flexion with elbow extension, circumduction with compression, circumduction with distraction, shoulder abduction and internal rotation with elbow flexion, shoulder adduction and external rotation with elbow

Muscle Energt Techinique (METs)

Eligibility Criteria

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

You may qualify if:

  • Patients with diabetic frozen shoulder
  • Patients having frozen shoulder after stroke
  • Subjects having stiff shoulder for at least 3 months
  • Subjects with bilateral/unilateral frozen shoulder
  • Subjects with idiopathic frozen shoulder

You may not qualify if:

  • Bone fracture within past 12 weeks
  • Patients with hyper mobile joints
  • Subjects with Rotator cuff pathology
  • Dislocated shoulder
  • Subjects who had shoulder arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johar pain relief center

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Bursitis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2024

First Posted

May 8, 2024

Study Start

September 1, 2023

Primary Completion

May 1, 2024

Study Completion

September 30, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations