Knee OsteoarthritisNCT04925895
Effects of Dynamic Soft Tissue Mobilization in Reducing Hamstring Tightness in Knee Osteoarthritis
A study testing Dynamic soft tissue mobilization, Proprioceptive neuromuscular facilitation stretching and Cryotherapy in people with Knee Osteoarthritis and Muscle Tightness, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The objective of this randomized control trial is to evaluate the effectiveness of dynamic soft tissue mobilization in comparison with the proprioceptive neuromuscular facilitation (hold-relax) technique in reducing hamstring muscle tightness, pain and improving physical functions in patients with knee osteoarthritis… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis, Muscle Tightness, Range of Motion
- What is being tested?
- Dynamic soft tissue mobilization, Proprioceptive neuromuscular facilitation stretching and Cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Apr 2021to 10 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders
- Subjects with 40 years of age and above
- Patients with hamstring tightness
- ACR clinical + radiological classification criteria for knee osteoarthritis
Who cannot join
- Patients with positive sciatic nerve test (SLR)
- Patients with neurological disorder impacting on lower extremity
- Musculoskeletal knee deformity e.g. varus
- Patients with lower limb internal fixation
- History of previous lower limb arthroplasty or another knee surgery
- Patients with history of infectious disease or malignancy effecting the lower extremity .
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- Using assistive device(stick/cane)
- History of spinal surgery
- Patient having low backache or sciatica
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Soft Tissue Mobilization vs Proprioceptive Neuromuscular Facilitation in Reducing Hamstring Muscle Tightness in Patients With Knee Osteoarthritis: a Randomized Control Trial
The objective of this randomized control trial is to evaluate the effectiveness of dynamic soft tissue mobilization in comparison with the proprioceptive neuromuscular facilitation (hold-relax) technique in reducing hamstring muscle tightness, pain and improving physical functions in patients with knee osteoarthritis by using Visual Analog Scale-10 cm, Active Knee Extension Angle Test in degree and Knee Injury and Osteoarthritis Outcome Score. This study will be carried out at Sindh Institute of Physical Medicine and Rehabilitation and Dow Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences, Karachi on the basis of non-probability purposive sample technique with screening for study criteria through a consultant physician (blinded) . After taking informed consent all participants will be randomly allocated into 2 groups i.e. 24 in interventional group 'A' and 24 in interventional group 'B' through second researcher who is not involved in screening, baseline assessment and providing intervention.The interventional group 'A' will received dynamic soft tissue mobilization on hamstring muscle along with cryotherapy on knee joint and isometric strengthening exercises for knee osteoarthritis while the interventional group 'B' will received proprioceptive neuromuscular facilitation (hold relax) technique on hamstring muscle along with cryotherapy on knee joint and isometric strengthening exercises for knee osteoarthritis. Twelve sessions will be given each of 30 minutes.Outcomes will be assessed at baseline and at last session.
Read the detailed description
All the participants will referred by the physiatrist as diagnosed with knee osteoarthritis. All the data will be collected within ethical constraints. Only principal investigator will access to the data as it will be in her custody. Patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management will be strictly performed within codes of ethics.
The sample size of 48 patients (24 in one group) is calculated by using open epi software version 3, Paired Means Power Analysis with 99% Confidence Interval and 95% power of test, mean ± S.D of VAS 5.27 ± 0.8 in group A and 3.81±1.4 in group B on the basis of previous findings. The missing data will be considered during analysis and results interpretation for any inconsistency in results.Data were stored and analyzed using IBM-SPSS version 23.0, Mean with standard deviation will be calculated for all quantitative variables. Counts with percentages will be presented for quantitative variables. parametric or non parametric tests will be used to compare outcome variables within and between groups after sessions completion. P-values less than 0.05 will be considered statistically significant.
- Being tested
- Dynamic soft tissue mobilization, Proprioceptive neuromuscular facilitation stretching, Cryotherapy, Isometric knee strengthening excercises
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic soft tissue mobilizationOther
Also called DSTM, dynamic soft tissue technique, soft tissue mobilization
Dynamic soft tissue mobilization will be given in the following sequence, In supine position with 90˚ flexion of knee and hip joint deep longitudinal strokes will be applied from distal to proximal direction along with the tightened area of hamstring while passively stretching the hamstring. Total 5 longitudinal strokes will be applied followed by shaking for 20 seconds. Then progressed to the next dynamic technique in the above-mentioned sequence but the patient will be asked to do leg extension actively to achieve reciprocal inhibition of the hamstring muscle. In The next step, the subject will apply a force to the therapist's hand to engage the hamstring eccentrically as the muscle will be lengthened to its end range. In that position, the therapist will apply 5 deep longitudinal strokes from the distal towards the proximal direction on tight hamstring muscles.
Proprioceptive neuromuscular facilitation stretchingOther
Also called PNF stretchings, PNF exercises, PNF stretching exercise
The position of the patient will be supine lying with 90⁰ flexion of hip. Therapist will passively extend the knee joint where patient will feel a mild stretch. Then therapist will ask the patient to do knee flexion in counter resistance applied by the therapist by using about 50% of his maximum strength and isometric contraction of hamstring muscles will be achieved. Patient will maintain that isometric contraction for 8 seconds then relax on therapist command. Just after relaxation therapist will further stretch the hamstring muscle to the point of mild to moderate painless stretch and patient will hold it for 30 seconds. Three repetitions will be applied in each session.
CryotherapyOther
Also called Cold pack, Icing
application of cold pack on knee joint for 10 minutes
Isometric knee strengthening excercisesOther
Also called Isometrics, knee strengthening exercises, Isometric quads
- Isometric hip adductors exercises in crook lying: Two sets of 10 repetitions with a 10-seconds hold will be carried out. ii. Isometric quadriceps strengthening exercises in supine lying: A towel roll underneath the knee joint will be used to perform this exercise. Two sets of 10 repetitions with a 10-seconds hold will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic soft tissue mobilization | Experimental | Dynamic soft tissue mobilization (DSTM) is a soft tissue mobilization technique use to treat tight spasm using progressive muscle activation. Receives: Other: Dynamic soft tissue mobilization; Other: Cryotherapy; Other: Isometric knee strengthening excercises |
| Proprioceptive neuromuscular facilitation stretching | Active comparator | PNF stretching technique, a type of flexibility training that is effective in improving muscle flexibility and restore functional ranges using a wide array of techniques. Receives: Other: Proprioceptive neuromuscular facilitation stretching; Other: Cryotherapy; Other: Isometric knee strengthening excercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale in centimetre
A bidirectional scale for subjective measurement for pain comprises of a 10 cm line labeling parallel on both sides, starts with least "no pain" (0 cm) and end on most "worst pain" (10 cm).
Measured: upto 4 weeks
Active Knee Extension Angle Test in degree
It will used to assessing the hamstring muscle length by using goniometry with 90° of hip flexion. higher the degree higher will be the knee extension.
Measured: upto 4 weeks
Secondary outcomes (1)
The Knee Injury and Osteoarthritis Outcome Score
It is a patient related outcome measure, having 5 sub-scales, designed to check disease development and outcomes followed by surgical, pharmaceutical, physical therapy or other interventions.100 indicates no problem and 0 indicates extreme problem.
Measured: upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start22 Apr 2021
- Primary completion1 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Model description
- A single blinded randomized control trial in which total 48 patients will be enrolled and randomly allocated into 2 interventional groups equally. The randomization will be carried out through an open source software "research randomizer" by statistician.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Shahzad Ali, Dow University of Health Sciences
- Investigators
- Khadija Nafees, MSAPT, Principal investigator, Dow University of Health SciencesShahzad Ali Syed, MSPT, Study chair, Dow University of Health SciencesAftab Ahmed Mirza Baig, MSAPT, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925895
- Sponsor's protocol ID
- 00003
- Status last verified
- Jan 2022
- First submitted
- 8 Jun 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nafees K, Baig AAM, Ali SS, Ishaque F. Dynamic soft tissue mobilization versus proprioceptive neuromuscular facilitation in reducing hamstring muscle tightness in patients with knee osteoarthritis: a randomized control trial. BMC Musculoskelet Disord. 2023 Jun 2;24(1):447. doi: 10.1186/s12891-023-06571-y.
PubMed 37268961
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Soft Tissue Mobilization vs Proprioceptive Neuromuscular Facilitation in Reducing Hamstring Muscle Tightness in Patients With Knee Osteoarthritis: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04925895
- Acronym / sponsor ID
- 00003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 14 Jun 2021 (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.
The objective of this randomized control trial is to evaluate the effectiveness of dynamic soft tissue mobilization in comparison with the proprioceptive neuromuscular facilitation (hold-relax) technique in reducing hamstring muscle tightness, pain and improving physical functions in patients with knee osteoarthritis by using Visual Analog Scale-10 cm, Active Knee Extension Angle Test in degree and Knee Injury and Osteoarthritis Outcome Score. This study will be carried out at Sindh Institute of Physical Medicine and Rehabilitation and Dow Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences, Karachi on the basis of non-probability purposive sample technique with screening for study criteria through a consultant physician (blinded) . After taking informed consent all participants will be randomly allocated into 2 groups i.e. 24 in interventional group 'A' and 24 in interventional group 'B' through second researcher who is not involved in screening, baseline assessment and providing intervention.The interventional group 'A' will received dynamic soft tissue mobilization on hamstring muscle along with cryotherapy on knee joint and isometric strengthening exercises for knee osteoarthritis while the interventional group 'B' will received proprioceptive neuromuscular facilitation (hold relax) technique on hamstring muscle along with cryotherapy on knee joint and isometric strengthening exercises for knee osteoarthritis. Twelve sessions will be given each of 30 minutes.Outcomes will be assessed at baseline and at last session.
Detailed description
All the participants will referred by the physiatrist as diagnosed with knee osteoarthritis. All the data will be collected within ethical constraints. Only principal investigator will access to the data as it will be in her custody. Patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management will be strictly performed within codes of ethics.
The sample size of 48 patients (24 in one group) is calculated by using open epi software version 3, Paired Means Power Analysis with 99% Confidence Interval and 95% power of test, mean ± S.D of VAS 5.27 ± 0.8 in group A and 3.81±1.4 in group B on the basis of previous findings. The missing data will be considered during analysis and results interpretation for any inconsistency in results.Data were stored and analyzed using IBM-SPSS version 23.0, Mean with standard deviation will be calculated for all quantitative variables. Counts with percentages will be presented for quantitative variables. parametric or non parametric tests will be used to compare outcome variables within and between groups after sessions completion. P-values less than 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single blinded randomized control trial in which total 48 patients will be enrolled and randomly allocated into 2 interventional groups equally. The randomization will be carried out through an open source software "research randomizer" by statistician.
| Arm | Type | Receives |
|---|---|---|
| Dynamic soft tissue mobilization | Experimental | Other: Dynamic soft tissue mobilization, Other: Cryotherapy, Other: Isometric knee strengthening excercisesDynamic soft tissue mobilization (DSTM) is a soft tissue mobilization technique use to treat tight spasm using progressive muscle activation. |
| Proprioceptive neuromuscular facilitation stretching | Active comparator | Other: Proprioceptive neuromuscular facilitation stretching, Other: Cryotherapy, Other: Isometric knee strengthening excercisesPNF stretching technique, a type of flexibility training that is effective in improving muscle flexibility and restore functional ranges using a wide array of techniques. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both genders
- Subjects with 40 years of age and above
- Patients with hamstring tightness
- ACR clinical + radiological classification criteria for knee osteoarthritis
Key exclusion criteria (9 listed)
- Patients with positive sciatic nerve test (SLR)
- Patients with neurological disorder impacting on lower extremity
- Musculoskeletal knee deformity e.g. varus
- Patients with lower limb internal fixation
- History of previous lower limb arthroplasty or another knee surgery
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 |
|---|---|---|
| Dynamic soft tissue mobilizationAlso: DSTM, dynamic soft tissue technique, soft tissue mobilizationDynamic soft tissue mobilization will be given in the following sequence, In supine position with 90˚ flexion of knee and hip joint deep longitudinal strokes will be applied from distal to proximal direction along with the tightened area of hamstring while passively stretching the hamstring. Total 5 longitudinal strokes will be applied followed by shaking for 20 seconds. Then progressed to the next dynamic technique in the above-mentioned sequence but the patient will be asked to do leg extension actively to achieve reciprocal inhibition of the hamstring muscle. In The next step, the subject will apply a force to the therapist's hand to engage the hamstring eccentrically as the muscle will be lengthened to its end range. In that position, the therapist will apply 5 deep longitudinal strokes from the distal towards the proximal direction on tight hamstring muscles. | Other | Dynamic soft tissue mobilization |
| Proprioceptive neuromuscular facilitation stretchingAlso: PNF stretchings, PNF exercises, PNF stretching exerciseThe position of the patient will be supine lying with 90⁰ flexion of hip. Therapist will passively extend the knee joint where patient will feel a mild stretch. Then therapist will ask the patient to do knee flexion in counter resistance applied by the therapist by using about 50% of his maximum strength and isometric contraction of hamstring muscles will be achieved. Patient will maintain that isometric contraction for 8 seconds then relax on therapist command. Just after relaxation therapist will further stretch the hamstring muscle to the point of mild to moderate painless stretch and patient will hold it for 30 seconds. Three repetitions will be applied in each session. | Other | Proprioceptive neuromuscular facilitation stretching |
| CryotherapyAlso: Cold pack, Icingapplication of cold pack on knee joint for 10 minutes | Other | Dynamic soft tissue mobilization, Proprioceptive neuromuscular facilitation stretching |
| Isometric knee strengthening excercisesAlso: Isometrics, knee strengthening exercises, Isometric quadsi. Isometric hip adductors exercises in crook lying: Two sets of 10 repetitions with a 10-seconds hold will be carried out. ii. Isometric quadriceps strengthening exercises in supine lying: A towel roll underneath the knee joint will be used to perform this exercise. Two sets of 10 repetitions with a 10-seconds hold will be performed. | Other | Dynamic soft tissue mobilization, Proprioceptive neuromuscular facilitation stretching |
Primary outcome
Visual analogue scale in centimetre
Time frame: upto 4 weeks
A bidirectional scale for subjective measurement for pain comprises of a 10 cm line labeling parallel on both sides, starts with least "no pain" (0 cm) and end on most "worst pain" (10 cm).
Active Knee Extension Angle Test in degree
Time frame: upto 4 weeks
It will used to assessing the hamstring muscle length by using goniometry with 90° of hip flexion. higher the degree higher will be the knee extension.
1 secondary outcome
The Knee Injury and Osteoarthritis Outcome Score
Time frame: upto 4 weeks
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 10 Feb 2022.
- Derived from this study: PubMed 37268961Nafees K, Baig AAM, Ali SS, Ishaque F. Dynamic soft tissue mobilization versus proprioceptive neuromuscular facilitation in reducing hamstring muscle tightness in patients with knee osteoarthritis: a randomized control trial. BMC Musculoskelet Disord. 2023 Jun 2;24(1):447. doi: 10.1186/s12891-023-06571-y.
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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.
Khadija Nafees, MSAPT principal investigator
Dow University of Health Sciences
Shahzad Ali Syed, MSPT study chair
Dow University of Health Sciences
Aftab Ahmed Mirza Baig, MSAPT principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic soft tissue mobilization, Proprioceptive neuromuscular facilitation stretching and Cryotherapy in people with Knee Osteoarthritis and Muscle Tightness, run by Dow University of Health Sciences 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 4 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 10 Feb 2022. 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?
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?
Visual analogue scale in centimetre (time frame: upto 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04925895, which also lists 1 linked publication.
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 10 Feb 2022.