| CTRI Number |
CTRI/2024/12/077812 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of weight bearing Exercises and core stability on Pain Relief and Physical Function in Knee Osteoarthritis |
|
Scientific Title of Study
|
Effects of PNF(Proprioceptive Neuromuscular Facilitation) stretching, proprioceptive exercises, and core stability exercises on pain and physical function in knee osteoarthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhavi Arun Pawar |
| Designation |
Student |
| Affiliation |
Dr APJ Abdul Kalam College Of Physiotherapy loni |
| Address |
Dr. APJ Abdul Kalam College Of Physiotherapy , 403, orthopedic physiotherapy department ,loni , Ahmednagar
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
7350828697 |
| Fax |
|
| Email |
vaibhavip1003@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tejas Borkar PT |
| Designation |
Assosciate Professor |
| Affiliation |
Dr APJ Abdul Kalam College Of Physiotherapy loni |
| Address |
Dr. APJ Abdul Kalam College Of Physiotherapy , 504, pediatrics physiotherapy department , loni , Ahmednagar
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
93712771752 |
| Fax |
|
| Email |
tejasborkar57@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vaibhavi Arun Pawar |
| Designation |
Student |
| Affiliation |
Dr APJ Abdul Kalam College Of Physiotherapy loni |
| Address |
Dr. APJ Abdul Kalam College Of Physiotherapy , 403, orthopedic physiotherapy department ,loni , Ahmednagar
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
7350828697 |
| Fax |
|
| Email |
vaibhavip1003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences,
Loni,413736 |
|
|
Primary Sponsor
|
| Name |
Dr. A.P.J Abdul Kalam College of Physiotherapy, PIMS , Loni |
| Address |
Pravara Institute of Medical Sciences, Dr. A.P.J Abdul Kalam
College of Physiotherapy , Loni, 413736 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vaibhavi Pawar |
Dr. A.P.J Abdul Kalam College of Physiotherapy, loni Ahmed Nagar |
Dr. APJ Abdul Kalam College Of Physiotherapy , 403, orthopedic physiotherapy department ,loni , Ahmednagar Ahmadnagar MAHARASHTRA |
7350828697
vaibhavip1003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Dr. APJAK COPT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Osteoarthritis |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Proprioceptive Neuromuscular Facilitation |
Hamstrings Stretch
Quadriceps Stretch
Medial and lateral knee stretches
Static balance on unstable surfaces (balance board)2 sets
of 10 reps
TENS
Week 1 to 2: -
Frequency – 3 sessions / week
Intensity – moderate
Time – 30 minutes
Type – stretching (hold 20 secs 2 sets)
-Modality (7 minute)
(10 reps 2 sets for each exercises)
|
| Comparator Agent |
Proprioceptive Neuromuscular Facilitation with core stability |
core stability exercise |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) 45 to 65 years of age
2) Both male and female
3) Diagnosed case of knee OA
4) Non operative OA patients |
|
| ExclusionCriteria |
| Details |
1) post operative OA
2) History of dislocation
3) History of fracture
4) History of trauma
5) Not willing to participate |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1] Senior fitness test – Timed up and go test
30 second chair stand test
2]WOMAC scale
|
week 0 to week 4
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
| Introduction: The most prevalent joint condition, osteoarthritis (OA), mostly affects the diarthrodial joints and is linked to a growing socioeconomic burden as a result of population aging. Increasing age and obesity are the two main risk factors for primary OA, however there are other factors as well. From being thought of as a cartilage-limited condition to a multifactorial illness affecting the entire joint, the idea of the pathogenesis is continually changing. Proprioceptive neuromuscular facilitation, or PNF stretching, is a type of flexibility training that helps lessen hyper tonus, enabling muscles to loosen up and lengthen. In order to maximize motor performance and facilitate rehabilitation, proprioceptive neuromuscular facilitation (PNF) stretching techniques are frequently employed in clinical and sporting settings to improve both active and passive range of motion. PNF methods aid in the development of joint stability, mobility, neuromuscular control, and coordination as well as muscle strength and endurance. In order to maximize motor performance and facilitate rehabilitation, proprioceptive neuromuscular facilitation (PNF) stretching techniques are frequently employed in clinical and sporting settings to improve both active and passive range of motion. 2 Techniques-- Contract Relax: The restricted muscle is passively stretched into a stretched posture, and then it is isometrically contracted. In PNF stretching techniques, the majority of isometric contractions should be held for at least three seconds. Hold Relax: This method is really comparable to Contract Relax. When the agonist is too weak to activate effectively, this is used. The patient is made to stretch their restricted muscle, and then they are made to contract isometrically. Most recognizable opponent for hold-relax. It can be applied to improve passive range of motion and extend tense muscles. Since the tight muscle in this approach is the antagonist, the agonist contracts. Hold-Relax Agonist: Most familiar. It can be used to lengthen out tight muscle and increase passive range of motion. In this technique, the tight muscle is the antagonist, hence the agonist contracts. The cornerstone of the treatment is physiotherapy. It includes stretching and strengthening exercises, thermotherapy, and electrotherapy (ultrasound, muscle stimulation). Additionally, braces and other supportive devices are used. The Proprioceptive Neuromuscular Facilitation (PNF) stretching technique has been demonstrated to enhance both passive and active range of motion while also increasing muscle flexibility. Proprioceptive neuromuscular facilitation (PNF) stretching may be a preferred intervention for KOA rehabilitation. PNF stretching was more effective than traditional stretching for pain relief.
| Weakness in the core muscles puts more strain on the knee joint and its contact when walking. Activating the functional kinetic chain that links the stability of the lower extremities is a component of strengthening core muscles As the population ages, osteoarthritis (OA), the most prevalent joint condition, is linked to a growing socioeconomic effect and primarily affects the diarthrodial joints. A number of risk factors contribute to primary OA, the two most common ones being obesity and advancing age. There are very few studies are done on stepping mechanism on osteoarthritis patient so, the need of study is to find out effect of proprioceptive neuromuscular facilitation (PNF) stretching in reducing pain and improving knee balance with knee osteoarthritis (OA). The study aims to investigate the effectiveness of proprioceptive neuromuscular facilitation (PNF) stretching and proprioceptive exercises along with core stability on pain and physical function in patients with knee osteoarthritis(OA). | RESEARCH QUESTION: Will there any effect of proprioceptive neuromuscular facilitation and proprioceptive exercises along with core stability on pain and physical function in knee osteoarthritis(OA)?
| AIM: To find the effect of proprioceptive neuromuscular facilitation and proprioceptive exercises along with core stability on pain and physical function in knee osteoarthritis(OA). OBJECTIVE OF THE STUDY: . To find effect of PNF and proprioceptive exercises along with core stability on pain. . To find effect of PNF and proprioceptive exercises along with core stability on physical function. | HYPOTHESIS H0: Null Hypothesis There is no significant effect of proprioceptive neuromuscular facilitation and proprioceptive exercises along with core stability on pain and physical function in knee osteoarthritis(OA). H1: alternative Hypothesis There is significant effect of proprioceptive neuromuscular facilitation and proprioceptive exercises along with core stability on pain and physical function in knee osteoarthritis(OA).
| METHODOLOGY: STUDY SETTING: Dr. A.P.J. Abdul Kalam College of Physiotherapy. DURATION OF STUDY: 4 weeks METHOD OF COLLECTION OF DATA: Dr. A.P.J. Abdul Kalam College of Physiotherapy TYPE OF DATA: quantitative | STUDY DESIGN: Randomize control trial STUDY TYPE: Intervention SAMPLING METHOD: simple random sampling | | OUTCOME MEASURES: 1] Senior fitness test – Timed up and go test 30 second chair stand test 2] WOMAC Scale | Inclusion criteria: 1.45-65 years of age 2. Both male and female 3. Diagnosed case of Knee OA 4. Non operative OA patients. Exclusion criteria: 1. post-operative OA 2. History of fracture 3. History of dislocation 4. History of trauma 5. Not willing to participate | PROCEDURE: Protocol is prepared and ethical will be obtained from the IEC. The participants will be selected based on the eligibility criteria. Informed consent will be obtained from the participants and demographic data will be recorded Participants will be randomly allocated to 2 group that is experimental group A(n=) and control group B(n=) prior assessment of the participant will be done Group A will be administered with proprioceptive neuromuscular facilitation stretching to Quadriceps, hamstrings and conventional physiotherapy treatment. Group B will be administered with proprioceptive exercises with core stability. | All the instruction will be given verbally, provided demonstration and guided through a single practice trial.
| REFERENCES: 1. Martel-Pelletier J, Barr AJ, Cicuttini FM, Conaghan PG, Cooper C, Goldring MB, Goldring SR, Jones G, Teichtahl AJ, Pelletier JP. Osteoarthritis. Nat Rev Dis Primers. 2016 Oct 13; 2:16072. doi: 10.1038/nrdp.2016.72. PMID: 27734845. 2. Nathani S, Tank KD. Effect of PNF stretching on proprioception and physical function in individual with knee osteoarthritis: An experimental study. Indian Journal of Public Health Research & Development. 2020 Jul 30;11(7):712-7. 3. Gao B, Li L, Shen P, Zhou Z, Xu P, Sun W, Zhang C, Song Q. Effects of proprioceptive neuromuscular facilitation stretching in relieving pain and balancing knee loading during stepping over obstacles among older adults with knee osteoarthritis: A randomized controlled trial. Plos one. 2023 Feb 13;18(2): e0280941. 4. Salehi N, Mohammadi HR, Poursamad A, Afrasiabifar A, Doulatabad SN. The Effect of Proprioceptive Neuromuscular Facilitation Techniques on Muscular Strength in Patients with Knee Osteoarthritis: A Quasi-Experimental Study. Jundishapur Journal of Chronic Disease Care. 2024;13(2). 5. Shen S, Mulgaonkar Y, Michael N, Kumar V. Multi-sensor fusion for robust autonomous flight in indoor and outdoor environments with a rotorcraft MAV. In2014 IEEE International Conference on Robotics and Automation (ICRA) 2014 May 31 (pp. 4974-4981). IEEE. | |
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