Knee OsteoarthritisNCT07256054
High-power Pain Threshold Ultrasound and Vibration Massage in Treatment Knee Osteoarthritis Patients
A study testing Conventional treatment, Vibration massage and High-power pain threshold ultrasound in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Conventional treatment, Vibration massage and High-power pain threshold ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adding High-power Pain Threshold Ultrasound to Vibration Massage on Calf Muscle Tightness in Knee Osteoarthritis Patients
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.
Read the 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
- Being tested
- Conventional treatment, Vibration massage, High-power pain threshold ultrasound
- Keywords
- High-power pain threshold ultrasound, Vibration massag, Calf muscle tightness, Knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional treatmentOther
- 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
- Calf and hamstring stretching
- Strengthening of the lower limb musculature (quadriceps) multi angle isometric exercises
- Straight leg raising exercise
- Mini squats
- Hip extension exercise
- Hip abduction and adduction with weights (side lying) using ankle weights
Vibration massageOther
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 ultrasoundOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Active comparator | Group (A) received conventional treatment. Receives: Other: Conventional treatment |
| Group (B) | Experimental | Group (B) received conventional treatment plus vibration massage Receives: Other: Conventional treatment; Other: Vibration massage |
| Group (C) | Experimental | Group (C) received conventional treatment, vibration massage and the high-power pain threshold ultrasound Receives: Other: Conventional treatment; Other: Vibration massage; Other: High-power pain threshold ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At enrollment and after 4 weeks of treatment
Secondary outcomes (3)
Pain intensity
Patients were asked to rate their pain intensity level on visual analogue scale in activities such as going up-and downstairs, sitting and squatting the minimum score is 1 and the maximum score is 10 higher scores mean worse outcome.
Measured: At enrollment and after 4 weeks of treatment
Pain threshold level
pressure pain thresholds (PPT) and temporal summation of sustained pressure pain was measured by using digital algometer. The primary outcome chosen was the PPT on the stretched calf. Constant pressure stimulation at 125% of the baseline PPT pressure (obtained at the first visit) was applied for 6 minutes. The participants rated the pain intensity continuously during the constant pressure stimulation on an electronic power of 0.81 to detect a mean difference in PPT at the stretched calf (primary outcome) of 5 kPa, which from content expert viewpoint seems relevant. Pressure pain points were measured over the calf muscle belly
Measured: At enrollment and after 4 weeks of treatment
Knee function Assessment
Universities Osteoarthritis Index (WOMAC) was used. The patient was informed with the questionnaire sub scales and was asked to fill the physical function subscale which consists of 17 items and pain which consists of 5 items. All items were evaluated from 0 which mean nothing, 1 means slight, 2 is moderate, 3 is very, and 4 is extreme. All discussions were in Arabic language.
The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68.A total WOMAC score is created by summing the items for all three subscales (0-96) higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations
Measured: At enrollment and after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Jun 2024
- Primary completion1 Jun 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Rafat, Cairo University
- Investigators
- Ragia M Kamel, Study chair, Physical Therapy faculty, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256054
- Sponsor's protocol ID
- Pt.Rec/2025-0065
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding High-power Pain Threshold Ultrasound to Vibration Massage on Calf Muscle Tightness in Knee Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT07256054
- Acronym / sponsor ID
- Pt.Rec/2025-0065
- Conditions
- Knee Osteoarthritis
- Keywords
- High-power pain threshold ultrasound, Vibration massag, Calf muscle tightness, Knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Active comparator | Other: Conventional treatmentGroup (A) received conventional treatment. |
| Group (B) | Experimental | Other: Conventional treatment, Other: Vibration massageGroup (B) received conventional treatment plus vibration massage |
| Group (C) | Experimental | Other: Conventional treatment, Other: Vibration massage, Other: High-power pain threshold ultrasoundGroup (C) received conventional treatment, vibration massage and the high-power pain threshold ultrasound |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional treatment1. 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 | Other | Group (A), Group (B), Group (C) |
| Vibration massage1- 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 ) | Other | Group (B), Group (C) |
| High-power pain threshold ultrasoundApplication 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 | Other | Group (C) |
Primary outcome
Calf muscle flexibility
Time frame: At enrollment and after 4 weeks of treatment
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
3 secondary outcomes
Pain intensity
Time frame: At enrollment and after 4 weeks of treatment
Pain threshold level
Time frame: At enrollment and after 4 weeks of treatment
Knee function Assessment
Time frame: At enrollment and after 4 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragia M Kamel study chair
Physical Therapy faculty, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional treatment, Vibration massage and High-power pain threshold ultrasound in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calf muscle flexibility (time frame: At enrollment and after 4 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.