High-power Pain Threshold Ultrasound and Vibration Massage in Treatment Knee Osteoarthritis Patients

NCT07256054 | Completed

• 1 other identifier: Pt.Rec/2025-0065
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Calf muscle have tendency of development of trigger points that can increase pain in patients with osteoarthritis. Purpose:To investigate the effect of adding high-power pain threshold ultrasound to vibration massage on calf muscle tightness, pain intensity, pain threshold, and knee function in knee osteoarthritis patients. Subject and methods: Sixty male and female patients diagnosed clinically by physician as having knee osteoarthritis grades II-III participated in the study. Their age ranged from 40 to 60 years. They were assigned randomly into three groups (A, B, C) equal in number. Group (A) received conventional treatment. Group (B) received conventional treatment plus vibration. Group (C) received conventional treatment, vibration and the high-power pain threshold ultrasound. Outcome measurements were taken before and after intervention, so patients received intervention for 12 sessions (three sessions per week). Tape measurement was used to measure the calf muscle flexibility, VAS to measure pain intensity, pressure algometer to measure pain threshold and WOMAC questionnaire to measure the knee functions.

Conditions

Knee Osteoarthritis

Keywords

High-power pain threshold ultrasound; Vibration massag; Calf muscle tightness; Knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Calf muscle flexibility

  Calf Muscle Tightness Test: the subject stands a short distance away from a wall, with one leg in front of the other. Keeping the heel of the front foot on the ground, try and bend at the knee and touch the knee to the wall. If done successfully, move further away from the wall and try again. Keep repeating this action until you are unable to touch the wall. Measure the distance from the front of the foot to the wall at the maximum distance the knee could touch the wall. Repeat the same procedure for each leg. Scoring: measure the maximum distance from the toe to the wall. There are no norms available for this test

  At enrollment and after 4 weeks of treatment

Secondary Outcomes (3)

• Pain intensity

  At enrollment and after 4 weeks of treatment

• Pain threshold level

  At enrollment and after 4 weeks of treatment

• Knee function Assessment

  At enrollment and after 4 weeks of treatment

Study Arms (3)

Group (A)

ACTIVE COMPARATOR

Group (A) received conventional treatment.

Other: Conventional treatment

Group (B)

EXPERIMENTAL

Group (B) received conventional treatment plus vibration massage

Other: Conventional treatment; Other: Vibration massage

Group (C)

EXPERIMENTAL

Group (C) received conventional treatment, vibration massage and the high-power pain threshold ultrasound

Other: Conventional treatment; Other: Vibration massage; Other: High-power pain threshold ultrasound

Interventions

Conventional treatment OTHER

1. TENS: Conventional TENS was used for 20 minutes to deliver asymmetrical rectangular biphasic pulsed electrical currents at a pulse repetition frequency (rate) of 100 Hz and pulse duration (width) of 250 Ksecs. The TENS was administered using two channels and four electrodes with the negative electrode (cathode) placed on the MTrP of the calf muscle and the positive electrode placed on the insertion of the muscle 2. Calf and hamstring stretching 3. Strengthening of the lower limb musculature (quadriceps) multi angle isometric exercises 4. Straight leg raising exercise 5. Mini squats 6. Hip extension exercise 7. Hip abduction and adduction with weights (side lying) using ankle weights

Group (A); Group (B); Group (C)

Vibration massage OTHER

1- Application of Vibration massage: Typical starting point is 30 seconds at a moderate speed for a typical trigger point (60 for chronic deep trigger points). There may be multiple trigger points in an area, each needing an application of massage. The medial gastrocnemius muscle was the focus of the first 2.5 minutes of the massage treatment, while the lateral gastrocnemius muscle was the focus of the second 2.5 minutes. Within 20 seconds, the massage system was shifted longitudinally in a straight line from distal to proximal and back to distal, starting at the very medial side of the treated muscle,we shifted the vibration massage unit laterally and longitudinally from distal to proximal and back to distal at the distal end of the muscle. The massage began on the medial side and ended on the lateral side for each muscle. We attempted to apply the same amount of force to the skin. The duration of the continuous vibratory massage intervention for calf muscle was 5 min (10 min )

Group (B); Group (C)

High-power pain threshold ultrasound OTHER

Application of High-power pain threshold ultrasound: Patient position: the subject lying down prone with foot out of bed. Therapist position: The therapist was standing at the patient's affected side's foot end. The high-power pain threshold ultrasound (HPPTUS) technique which US is applied in continuous mode with intensity from 0.5 to 2 watt/cm to elicit pain threshold the US probe was kept motionless, and the intensity progressively increased until the maximum level of pain patient can endure was selected, it was maintained on this level for 3 to 4 seconds and then decreased to half intensity for 15 seconds the treatment process was repeated three times

Group (C)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 40 to 60 years' patients of chronic knee OA
• Patient with unilateral knee OA grade II-III Kellgren and Lawrence (K/L)
• Patients with BMI \< 30 kg/m² (not being classified as obese).
• Patients who are able to walk with painful knee OAwithoutassistive devices.
• Patients with knee pain intensity level at least \>3 cm on a 10 cm. VAS scale in activities such as going up-and downstairs, sitting and squatting.

You may not qualify if:

• Radiated pain from low back pain.
• No radiographic evidence of knee OA or with mild OA (grade I according to K/L classification) or with severe OA (grade IV according to K/L classification).
• Bilateral knee OA.
• Loss of joint play in tibiofemoral and patellofemoral articulations.
• Lower extremity fracture and surgery or trauma to the knee joint.
• Neurological deficit or movement disorder related to lower limb.
• Athletes or who had been treated with physiotherapy or medications during the previous 6 weeks.
• Those who could not apply vibration and percussion stimuli.
• Those who had varicose veins.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Physical Therapy faculty, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ragia M Kamel

  Physical Therapy faculty, Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor pf physical therapy

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: December 1, 2025
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 30, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)