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Calf Muscle Pain in Diabetic Neuropathy

A Comparative study to find the effectiveness of myofascial release over conventional exercise on calif muscle pain and functional activities in diabetic neuropathy patients - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090723
Enrollment
118
Registered
2025-07-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F- Physical Rehabilitation and Diagnostic Audiology

Interventions

Intervention1: MYOFASCIAL RELEASE: Functional exercises Intervention2: Myofascial Release: To evaluate the effectiveness of myofascial release in calf muscles to reducing pain Diabetic Neuropathy pati

Sponsors

ACS Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 30-70 years diagnosed with type 2 diabetes mellitus. 2. Confirmed diagnosis of diabetic neuropathy (based on clinical tests like Michigan Neuropathy Screening Instrument or nerve conduction studies). 3. Presence of calf muscle dysfunction, including symptoms such as pain, stiffness, reduced strength, or limited range of motion. 4. Pain intensity in the calf region rated as greater than 4 on the Numeric Pain Rating Scale(NRS). 5. Ability to walk independently or with minimal assistance. 6. Willingness to participate and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1 Diagnosis of type 1 diabetes or other non-diabetic neuropathies 2 Presence of severe peripheral arterial disease ankle-branchial index is lesser than 0.7 3 History of lower limb fractures surgeries or conditions like Achilles tendonitis or plantar fasciitis in the past 6 months 4 Severe musculoskeletal disorders affecting the lower limbs arthritis or joint deformities 5 Any coexisting neurological conditions eg stroke multiple sclerosis) that may interfere with functional assessment 6 Active foot ulcers, infections, or other diabetic foot complications 7 Use of opioids or other strong analgesics that may alter pain perception during the study period. 8. Participation in another clinical trial or physical therapy program in the last 3 months. 9. Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Calf Muscle PainTimepoint: Calf Muscle Function Improvement in muscle strength, as measured by a handheld dynamometer. Increased range of motion (ROM) in the ankle joint, assessed using a goniometer. Enhanced flexibility of the calf muscles, as determined by standard flexibility Tests.

Secondary

MeasureTime frame
1 To evaluate the impact of myofascial release versus conventional exercise on pain intensity in the calf muscles, as measured by the Numeric Pain Rating Scale NRS 2 To assess the changes in functional activity using the Lower Extremity Functional Scale LEFS in both intervention groups 3 To determine the effects of the interventions on muscle stiffness & tension in the calf muscles 4 To analyses participant-reported satisfaction & perceived benefits of each intervention. 5 To investigate the potential role of myofascial release & conventional exercise in reducing the risk of falls & improving balance in individuals with diabetic neuropathy 6. To compare the long-term sustainability of the functional & pain-relief benefits provided by the two interventions Timepoint: 18 session of six week period;Improvement in muscle strength, as measured by a handheld dynamometer. Increased range of motion (ROM) in the ankle joint, assessed using a goniometer. Enhanced flexibility of the calf muscles, as determined by standard flexibility Timepoint: LEFS BIOTHESIOMETER GONIOMETER

Countries

India

Contacts

Public ContactSARAVANAN

Dr MGR Educational and Research institute

mohankumar.physio@drmgrdu.ac.in9791072249

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026