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

NCT05580705 | Completed

• 1 other identifier: Sajawal Bashir
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetes Mellitus; Vibration Therapy; Diabetic Neuropathy; Pain; Balance; Functional Disability; Patient satisfaction; Routine Physical Therapy

Outcome Measures

Primary Outcomes (4)

• Pain Intensity

  Pain Intensity will be measured by using Numeric Pain Rating Scale. Pain score range from 1-10, with 1 indicates least possible pain level and 10 is the worst pain level.

  Change in pain score will be measured at baseline, at the end of 1st week and 2nd week.

• Dynamic and Static Balance

  Dynamic and static balance will be measured by using Berg Balance Scale. Its score range from 0 to 56, lower score represents more chances of losing balance and requirement of assistive measures.

  Change in Balance score will be measured at baseline, at the end of 1st week and 2nd week.

• Level of Functional Disability

  Functional Disability will be measured by using Revised Neuropathy Disability Score. The total score is 10 with higher score indicates more severity of disease.

  Change in Functional Disability score will be measured at baseline, at the end of 1st week and 2nd week

• Patient Satisfaction Level

  Patient Satisfaction Level will be measured by the Patient Satisfaction Questionnaire. Total score is 90. and higher score towards maximum value indicates higher level of satisfaction.

  Change in Patient Satisfaction Level will be measured at baseline, at the end of 1st week and 2nd week.

Study Arms (2)

ROUTINE PHYSICAL THERAPY GROUP

ACTIVE COMPARATOR

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.

Other: Routine Physical Therapy

VIBRATION THERAPY

EXPERIMENTAL

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.

Other: Vibration Therapy

Interventions

Routine Physical Therapy OTHER

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

ROUTINE PHYSICAL THERAPY GROUP

Vibration Therapy 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.

VIBRATION THERAPY

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 40269358 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Neuropathies; Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It will be a single blinded study and the outcome assessor will be blinded to the treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: September 22, 2022
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending on 36th month

Locations

PA (1)