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

NCT ID: NCT07256054

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-08-30

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.

Detailed Description

The current study was conducted to investigate the therapeutic effect of adding high-power pain threshold ultrasound to vibration massage on calf muscle tightness,pain intensity, pain threshold and knee function in patients with knee osteoarthritis.The study was conducted on 60 volunteer patients (age 40-60 years) suffering from unilateral knee OA grade II-III.Group (A): consisted of 20 patientsreceived the conventional physical therapy program only (Control group). Group (B): consisted of 20 patientsReceived conventional physical therapy program in addition to vibration massage. Group (C): consisted of 20 patientsreceived high-power pain threshold ultrasound in addition to conventional physical therapy program and the vibration massage. 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. SPSS software version 22 was used to conduct all statistical analyses.

Conditions

Knee Osteoarthritis

Study Design

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

Study Groups

Group (A)

Group (A) received conventional treatment.

Group Type: ACTIVE_COMPARATOR

Conventional treatment

Intervention Type: 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 (B)

Group (B) received conventional treatment plus vibration massage

Group Type: EXPERIMENTAL

Conventional treatment

Intervention Type: 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

Vibration massage

Intervention Type: 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 (C)

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

Group Type: EXPERIMENTAL

Conventional treatment

Intervention Type: 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

Vibration massage

Intervention Type: 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 )

High-power pain threshold ultrasound

Intervention Type: 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

Interventions

Conventional treatment

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

Intervention Type: OTHER

Vibration massage

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 )

Intervention Type: OTHER

High-power pain threshold ultrasound

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age from 40 to 60 years' patients of chronic knee OA

2. Patient with unilateral knee OA grade II-III Kellgren and Lawrence (K/L)

3. Patients with BMI < 30 kg/m² (not being classified as obese).

4. Patients who are able to walk with painful knee OAwithoutassistive devices.

5. 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Doaa Rafat

Assistant professor pf physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ragia M Kamel

Role: STUDY_CHAIR

Physical Therapy faculty, Cairo University

Locations

Physical Therapy faculty, Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Pt.Rec/2025-0065

Identifier Type: -

Identifier Source: org_study_id