NCT07161622

Brief Summary

The current study is to evaluate the comparative effects of low-level laser therapy and muscle energy technique on pain, range of motion, and functional results in diabetic patients with frozen shoulder. This research aims to enhance the existing data on managing diabetes-related musculoskeletal issues by assessing the comparative advantages of various therapies, therefore assisting physicians in choosing appropriate, patient-centred rehabilitation procedures.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 5, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

Frozen shoulderLow-Level Laser TherapyMuscle Energy Technique,Range of MotionDiabetes

Outcome Measures

Primary Outcomes (1)

  • Shoulder function

    Measured using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, a validated patient-reported outcome measure assessing disability and symptoms related to upper limb musculoskeletal disorders. Higher scores indicate greater disability.

    Baseline, 4 weeks, and 8 weeks after intervention initiation.

Study Arms (2)

Low-Level Laser Therapy (LLLT) + Conventional Therapy

EXPERIMENTAL

Participants received LLLT with a Ga-Al-As diode laser (830 nm, 100 mW) applied to anterior capsule, posterior capsule, and subacromial area (4 J/cm² per site, 60-90 sec each), three times per week for 8 weeks. Along with LLLT, all participants received conventional therapy (moist heat, pendulum exercises, passive/active-assisted ROM, isometric strengthening, and postural correction training).

Other: Low-Level Laser Therapy (LLLT)Other: Muscle Energy Technique (MET)

Muscle Energy Technique (MET) + Conventional Therapy

EXPERIMENTAL

Participants received MET for shoulder muscle groups (internal/external rotators, flexors, extensors). Each contraction was \~20% effort, held for 10 sec, followed by 5 sec relaxation and passive stretch to a new end range. Three to five cycles per group, \~20 minutes/session, three times per week for 8 weeks. Along with MET, all participants received the same conventional therapy as Arm A.

Other: Low-Level Laser Therapy (LLLT)Other: Muscle Energy Technique (MET)

Interventions

Participants received LLLT using a gallium-aluminium-arsenide (Ga-Al-As) diode laser device (BTL-5000, UK). The laser operated at a wavelength of 830 nm and a power output of 100 mW. Irradiation was applied at three sites (anterior capsule, posterior capsule, subacromial area) using a stationary-contact technique for 60-90 seconds each, delivering 4 J/cm² per site. Sessions were administered three times weekly for eight weeks. Conventional Therapy (for both groups): 15 minutes of moist heat (Chattanooga Hydrocollator) Pendulum exercises Passive and active-assisted ROM exercises Isometric strengthening of rotator cuff and scapular stabilizers Postural correction training

Low-Level Laser Therapy (LLLT) + Conventional TherapyMuscle Energy Technique (MET) + Conventional Therapy

Participants received MET for major shoulder muscles (internal/external rotators, flexors, extensors). Each contraction was performed at \~20% of maximum effort, sustained for 10 seconds, followed by 5 seconds relaxation, and then passive stretch to new end range. Three to five cycles per muscle group were performed. Sessions lasted \~20 minutes, three times weekly for eight weeks. Conventional Therapy (same as Arm A): 15 minutes of moist heat Pendulum exercises Passive and active-assisted ROM exercises Isometric strengthening of rotator cuff and scapular stabilizers Postural correction training

Low-Level Laser Therapy (LLLT) + Conventional TherapyMuscle Energy Technique (MET) + Conventional Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible participants were male and female individuals aged 18 to 65 years with a verified diagnosis of type 2 diabetes mellitus and clinical manifestations of frozen shoulder for at least three months. The diagnosis was determined by limited glenohumeral joint mobility, characterised by a decrease of ≥20° in a minimum of three active movements: flexion \<144°, abduction \<120°, and external rotation \<72°. Cases of both unilateral and bilateral nature were incorporated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BursitisDiabetes Mellitus

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Aqsa Majeed

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 8, 2025

Study Start

October 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

September 18, 2025

Record last verified: 2025-09