Comparing Low-Level Laser and Muscle Energy Techniques in Diabetic Frozen Shoulder

NCT ID: NCT07161622

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-02-28

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.

Conditions

Frozen Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low-Level Laser Therapy (LLLT) + Conventional Therapy

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).

Group Type: EXPERIMENTAL

Low-Level Laser Therapy (LLLT)

Intervention Type: OTHER

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

Muscle Energy Technique (MET)

Intervention Type: OTHER

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

Muscle Energy Technique (MET) + Conventional Therapy

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.

Group Type: EXPERIMENTAL

Low-Level Laser Therapy (LLLT)

Intervention Type: OTHER

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

Muscle Energy Technique (MET)

Intervention Type: OTHER

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

Interventions

Low-Level Laser Therapy (LLLT)

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

Intervention Type: OTHER

Muscle Energy Technique (MET)

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Aqsa Majeed

Dr. Aqsa Majeed

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Zunaira

Identifier Type: -

Identifier Source: org_study_id