Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy

NCT ID: NCT05580705

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-22
• Study Completion Date: 2023-02-22

Brief Summary

The study is aimed to determine the effects of sole-foot vibration therapy on pain intensity, static and dynamic balance, functional status and satisfaction to the intervention applied on patients with peripheral neuropathy due to type 2 diabetes mellitus.

Detailed Description

Peripheral Diabetic Neuropathy has disastrous effects on human body. It causes impairment which makes normal functioning and activity of daily life difficult. Vibration therapy improves neural mechano-sensitivity to promote movement and function.

In Pakistan, researches have been conducted only on Whole-body vibration and no data is available on foot-sole vibration therapy which is convenient to apply and appropriate for patients as there will be no fear of fall associated during treatment. Therefore, the aim of this study is to analyze the effects of vibration therapy, applied locally on foot, on pain management, balance adjustment, function and satisfaction to treatment in patients with diabetic neuropathy.

Conditions

Diabetic Peripheral Neuropathy

Study Design

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

Study Groups

ROUTINE PHYSICAL THERAPY GROUP

This group will receive routine physical therapy including strength training intervention. This protocol will be given for two weeks (6 sessions on alternate days, 3 sessions per week), outcomes will be measured at baseline, at the end of 1st week and 2nd week.

Group Type: ACTIVE_COMPARATOR

Routine Physical Therapy

Intervention Type: OTHER

The Routine Physiotherapy treatment will include Transcutaneous Electrical Nerve Stimulation, Hot pack, Range of Motion (ROM) Exercises and Muscle Strengthening Exercises

VIBRATION THERAPY

This group will receive routine physical therapy and vibration therapy. This protocol will be given for two weeks (6 sessions on alternate days, 3 sessions per week), outcomes will be measured at baseline, at the end of 1st week and 2nd week.

Group Type: EXPERIMENTAL

Vibration Therapy

Intervention Type: OTHER

Vibration Therapy will include a vibration device of brand Manipol, model number RK-001. It has 360 degree off-centered axis with a frequency of 2500 times per minute. It will be applied on sole of the foot for about 15 mins.

Interventions

Routine Physical Therapy

The Routine Physiotherapy treatment will include Transcutaneous Electrical Nerve Stimulation, Hot pack, Range of Motion (ROM) Exercises and Muscle Strengthening Exercises

Intervention Type: OTHER

Vibration Therapy

Vibration Therapy will include a vibration device of brand Manipol, model number RK-001. It has 360 degree off-centered axis with a frequency of 2500 times per minute. It will be applied on sole of the foot for about 15 mins.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age of 40-75 years
• Both male and female participants
• On oral medicine for diabetes
• HbA1C <8.5%, and controlled blood sugar in the last three months
• Patients with < 6 years from diagnosis of diabetes
• Diagnosed patient of peripheral neuropathy having type 2 diabetes by registered medical practitioner
• Patient is able to stand on both feet.

Exclusion Criteria

• Systemic diseases such as advanced cardiovascular, renal, or hepatic diseases
• Open wounds/ulcers on lower limb
• Neurological illness that affects balance i.e. vertebral artery syndrome, Multiple Sclerosis, Parkinson's disease, Alzheimer's disease, Stroke and cerebral ataxia
• Musculoskeletal problems such as leg length discrepancy, ankle sprain and severe osteoarthritis of knee and hip joints
• Patients who have performed vibration therapy exercises prior to intervention
• Patient under any antihypertensive drugs and blood pressure more than 160/95 mm hg

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Ayesha Jamil

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

Bashir S, Jamil A, Ali S. Effects of vibration therapy with routine physical therapy on pain, balance, and functional disability in diabetic neuropathy patients: a randomised controlled trial. J Pak Med Assoc. 2025 Apr;75(4):534-539. doi: 10.47391/JPMA.20058.

Reference Type: DERIVED

PMID: 40269358 (View on PubMed)

Other Identifiers

Sajawal Bashir

Identifier Type: -

Identifier Source: org_study_id