Knee OsteoarthritisOANCT07128875
Therapeutic Exercises for Pain and Disability in Knee Osteoarthritis
A study testing Exercise + TENS + Hot Pack and Exercise in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to evaluate the effectiveness of structured therapeutic exercises in reducing pain and disability among older adults diagnosed with knee osteoarthritis. The intervention will involve a supervised physical therapy program targeting muscle strength, joint mobility, and functional capacity. Read more about this study
- Who is it for?
- Ages 35 to 40 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise + TENS + Hot Pack and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Aug 2025to 17 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with knee OA
- Aged 50-75 years
- Experiencing pain or functional limitation
- Able to attend supervised sessions
- Provided informed consent
Who cannot join
- Severe cardiovascular or neurological conditions
- Acute injury or fracture in lower limb
- Uncontrolled hypertension or diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Riphah international University Malakand Campus
Malakand, Kpk, 23060
About this study
Official title: Effectiveness of Therapeutic Exercises in Reducing Pain and Disability in Knee Osteoarthritis Patients in Older Adults
This study aims to evaluate the effectiveness of structured therapeutic exercises in reducing pain and disability among older adults diagnosed with knee osteoarthritis. The intervention will involve a supervised physical therapy program targeting muscle strength, joint mobility, and functional capacity. Participants will undergo 6 weeks of therapy, and improvements in pain and physical function will be measured using validated scales.
Read the detailed description
Knee osteoarthritis (OA) is a leading cause of chronic pain and mobility limitations in the elderly population. Therapeutic exercises play a significant role in managing OA symptoms by strengthening the quadriceps, improving joint flexibility, and reducing stiffness. This study will enroll 60 participants aged 50-75 years diagnosed with knee OA. They will undergo a combination of strengthening, range of motion (ROM), and stretching exercises tailored to their condition. The intervention also includes adjunctive modalities such as hot pack and TENS to reduce pain and facilitate muscle engagement. Outcome measures will assess pain intensity, functional ability, and lower limb endurance before and after the intervention.
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercise + TENS + Hot Pack, Exercise
- Keywords
- Osteoarthritis, Knee Pain, Therapeutic Exercise
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise + TENS + Hot PackOther
Therapeutic Exercises with Hot Pack and TENS This intervention focuses on improving physical function and reducing pain through structured therapeutic exercises for knee OA patients. The program includes Warm-Up (10 min): Light walking or stationary cycling. 2. Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension. 3. Strengthening Exercises:
Quadriceps sets Straight leg raises Mini squats (pain-free range)
Seated knee extensions with resistance band 4. Stretching Exercises:
Hamstring stretch Calf stretch Quadriceps stretch 5. Cool Down (5-10 min): Breathing and relaxation. 6. Hot Pack (15 min) + TENS (10 min): Applied pre and post exercises for pain relief and muscle relaxation.
ExerciseOther
Warm-Up (10 min): Light walking or stationary cycling. 2. Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension. 3. Strengthening Exercises:
Quadriceps sets Straight leg raises Mini squats (pain-free range)
Seated knee extensions with resistance band 4. Stretching Exercises:
Hamstring stretch Calf stretch Quadriceps stretch 5.
| Study group | Role | What they receive |
|---|---|---|
| Exercise + TENS + Hot Pack | Experimental | Participants in this group will receive a structured therapeutic exercise program designed to improve physical function and reduce pain in patients with knee osteoarthritis.
The session includes:
Warm-Up (10 min): Light walking or stationary cycling
Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension
Strengthening Exercises:
Quadriceps sets
Straight leg raises
Mini squats (within pain-free range)
Seated knee extensions using resistance bands
Stretching Exercises:
Hamstring stretch
Calf stretch
Quadriceps stretch
Cool Down (5-10 min): Breathing and relaxation techniques
Modalities:
Hot Pack: 15 minutes (applied pre- and post-exercise)
TENS: 10 minutes (applied pre- and post-exercise using dual-channel portable TENS unit - [Brand/Model, if available]) Receives: Other: Exercise + TENS + Hot Pack |
| Exercise Only (Control) | Active comparator | Participants in the control group will follow the same structured therapeutic exercise program as the experimental group. However, TENS will be replaced with a sham procedure that mimics device placement without electrical stimulation.
Warm-Up (10 min): Light walking or stationary cycling
Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension
Strengthening Exercises:
Quadriceps sets
Straight leg raises
Mini squats (within pain-free range)
Seated knee extensions using resistance bands
Stretching Exercises:
Hamstring stretch
Calf stretch
Quadriceps stretch
Cool Down (5-10 min): Breathing and relaxation techniques
Modalities:
Hot Pack: 15 minutes (if applicable)
Sham TENS: Electrodes applied without current Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be assessed using the Visual Analog Scale (VAS), which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse outcomes.
Measured: 6 Months
Secondary outcomes (1)
Change in Physical Disability
Physical disability will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC consists of 24 items scored from 0 (none) to 4 (extreme), yielding a total score range from 0 to 96, where higher scores indicate worse disability
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start17 Aug 2025 (estimated)
- Primary completion17 Jul 2026 (estimated)
- Study completion17 Jul 2026 (estimated)
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 Riphah International 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A Therapeutic Group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Nadeem Ahmad, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128875
- Sponsor's protocol ID
- RIPHAH-REC Naimat ullah 01018
- Acronym
- OA
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2025
- Last updated
- 19 Aug 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 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Therapeutic Exercises in Reducing Pain and Disability in Knee Osteoarthritis Patients in Older Adults
- ClinicalTrials.gov ID
- NCT07128875
- Acronym / sponsor ID
- OA / RIPHAH-REC Naimat ullah 01018
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Knee Pain, Therapeutic Exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 17 Aug 2025 (estimated)
- Primary completion
- 17 Jul 2026 (estimated)
- Study completion
- 17 Jul 2026 (estimated)
- First posted
- 19 Aug 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.
This study aims to evaluate the effectiveness of structured therapeutic exercises in reducing pain and disability among older adults diagnosed with knee osteoarthritis. The intervention will involve a supervised physical therapy program targeting muscle strength, joint mobility, and functional capacity. Participants will undergo 6 weeks of therapy, and improvements in pain and physical function will be measured using validated scales.
Detailed description
Knee osteoarthritis (OA) is a leading cause of chronic pain and mobility limitations in the elderly population. Therapeutic exercises play a significant role in managing OA symptoms by strengthening the quadriceps, improving joint flexibility, and reducing stiffness. This study will enroll 60 participants aged 50-75 years diagnosed with knee OA. They will undergo a combination of strengthening, range of motion (ROM), and stretching exercises tailored to their condition. The intervention also includes adjunctive modalities such as hot pack and TENS to reduce pain and facilitate muscle engagement. Outcome measures will assess pain intensity, functional ability, and lower limb endurance before and after the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A Therapeutic Group
| Arm | Type | Receives |
|---|---|---|
| Exercise + TENS + Hot Pack | Experimental | Other: Exercise + TENS + Hot PackParticipants in this group will receive a structured therapeutic exercise program designed to improve physical function and reduce pain in patients with knee osteoarthritis. The session includes: Warm-Up (10 min): Light walking or stationary cycling Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension Strengthening Exercises: Quadriceps sets Straight leg raises Mini squats (within pain-free range) Seated knee extensions using resistance bands Stretching Exercises: Hamstring stretch Calf stretch Quadriceps stretch Cool Down (5-10 min): Breathing and relaxation techniques Modalities: Hot Pack: 15 minutes (applied pre- and post-exercise) TENS: 10 minutes (applied pre- and post-exercise using dual-channel portable TENS unit - [Brand/Model, if available]) |
| Exercise Only (Control) | Active comparator | Other: ExerciseParticipants in the control group will follow the same structured therapeutic exercise program as the experimental group. However, TENS will be replaced with a sham procedure that mimics device placement without electrical stimulation. Warm-Up (10 min): Light walking or stationary cycling Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension Strengthening Exercises: Quadriceps sets Straight leg raises Mini squats (within pain-free range) Seated knee extensions using resistance bands Stretching Exercises: Hamstring stretch Calf stretch Quadriceps stretch Cool Down (5-10 min): Breathing and relaxation techniques Modalities: Hot Pack: 15 minutes (if applicable) Sham TENS: Electrodes applied without current |
Who may qualify
- Ages
- 35 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed with knee OA
- Aged 50-75 years
- Experiencing pain or functional limitation
- Able to attend supervised sessions
- Provided informed consent
Key exclusion criteria (3 listed)
- Severe cardiovascular or neurological conditions
- Acute injury or fracture in lower limb
- Uncontrolled hypertension or diabetes
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 |
|---|---|---|
| Exercise + TENS + Hot PackTherapeutic Exercises with Hot Pack and TENS This intervention focuses on improving physical function and reducing pain through structured therapeutic exercises for knee OA patients. The program includes Warm-Up (10 min): Light walking or stationary cycling. 2. Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension. 3. Strengthening Exercises: Quadriceps sets Straight leg raises Mini squats (pain-free range) Seated knee extensions with resistance band 4. Stretching Exercises: Hamstring stretch Calf stretch Quadriceps stretch 5. Cool Down (5-10 min): Breathing and relaxation. 6. Hot Pack (15 min) + TENS (10 min): Applied pre and post exercises for pain relief and muscle relaxation. | Other | Exercise + TENS + Hot Pack |
| ExerciseWarm-Up (10 min): Light walking or stationary cycling. 2. Range of Motion (ROM) Exercises: Heel slides, seated knee flexion/extension. 3. Strengthening Exercises: Quadriceps sets Straight leg raises Mini squats (pain-free range) Seated knee extensions with resistance band 4. Stretching Exercises: Hamstring stretch Calf stretch Quadriceps stretch 5. | Other | Exercise Only (Control) |
Primary outcome
Pain Intensity
Time frame: 6 Months
Pain intensity will be assessed using the Visual Analog Scale (VAS), which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse outcomes.
1 secondary outcome
Change in Physical Disability
Time frame: 6months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Dr Nadeem Ahmad, MS principal investigator
Riphah International 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 Exercise + TENS + Hot Pack and Exercise in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
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 3 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: opening soon, as of the sponsor's last update on 19 Aug 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr.Nadeem Ahmad, MS (03451915105, n.ahmad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 6 Months). 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 19 Aug 2025.