IRCT | Comparison of the Non-thrust Manipulation VS. Muscle Energy Techniques in the Management of Patients with Knee Osteoarthritis: A Randomized Clinical Trial.

Protocol summary

Study aim: To evaluate the effectiveness of manipulation as compared with muscle energy techniques both with supervised exercise and electrical stimulation on pain, range of motion, performance and disability in patients with knee osteoarthritis.
Design: A concealed blinded, randomized, clinical trial with a parallel group design of 42 patients. Sequential numbers using an online randomization website will be used.
Settings and conduct: In patients with knee osteoarthritis (OA), joint mechanics and ineffective muscle working affect performance, and joint alignment. So the present study intends to evaluate the effectiveness of manipulation as compared with muscle energy technique on range of motion and performance of patients with knee OA, who refer to the physiotherapy clinic of the school of rehabilitation. The study will be double blinded (participant, accessor, analyzer) and coding to the evaluation forms will be used for blinding.
Participants/Inclusion and exclusion criteria: Patients with chronic knee Osteoarthritis (OA) (35- 65 years old, Visual Analogue Scale >=30mm, extension lack >10, Grade 2 OA) will be included. Patients with acute pain and inflammation, recent fractures and trauma, prolonged immobilization, severe cardiopulmonary disease, osteoporosis, rheumatoid arthritis, neurological disorders, and hip or knee arthroplasty will be excluded.
Intervention groups: In the group A, will receive manipulation included tibiofemoral distraction, anterior and posterior glide of the tibia on the femur and patellofemoral glide. In the group B, muscle energy technique will be used. Both of the intervention groups received the same supervised exercises and electrical stimulation.
Main outcome variables: Pain intensity at rest and during activity , 6-minute Walking Test, 30 Chair Stand Test, Lack of Knee Extension , Tibio-Femoral Angle, and Western Ontario and McMaster Universities scale.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20210214050356N2

Registration date: 2021-10-17, 1400/07/25

Registration timing: prospective

Last update: 2021-10-17, 1400/07/25

Update count: 0
Registration date: 2021-10-17, 1400/07/25

Registrant information: Name

Sara Fereydounnia

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 7752 8468

Email address

s-fereydounnia@sina.tums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2021-10-23, 1400/08/01
Expected recruitment end date: 2022-01-21, 1400/11/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the Non-thrust Manipulation VS. Muscle Energy Techniques in the Management of Patients with Knee Osteoarthritis: A Randomized Clinical Trial.

Public title: Comparison of the Manual Therapy and Muscle Contraction in the treatment of Patients with Knee Arthrosis
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Patients with knee OA (diagnosed already) Age 35 -65 years Grade 2 Kellgren-Lawrence radiographic confirmed OA Unilateral or bilateral knee OA. Chronic stages of knee pain. Patients who scored 30mm out of 100mm knee pain or greater on the VAS with activity intervention at baseline. Those who consented were able to ambulate at least 30 meters on an even surface with or without a walking device and were able to perform physical exercises with minimal support. WOMAC score above 10. Knee extension lack 10 degrees or more.

Exclusion criteria:

Acute pain and inflammation. Recent fractures. Patients having other major musculoskeletal problems and having with red flag signs and patients with recent history of knee trauma.• Prolonged immobilization. Uncontrolled hypertension. Severe cardiopulmonary disease. Mentally challenged. Severe osteoporosis. Rheumatoid arthritis. Neurological disorders affecting lower limb. Individuals with impaired function such as stroke, neoplastic disorder and hip or knee arthroplasty. Gout or Psedo-gout. Hyper/ hypo-thyroidism.
Age: From 35 years old to 65 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Outcome assessor
Data analyser

Sample size

Target sample size: 42

Randomization (investigator's opinion)

Randomized

Randomization description

After the baseline assessment, the participants will be randomized into one of the two intervention groups using simple randomization procedure. Forty two cards will be collected inside a ball with no clinical involvement in the study to ensure allocation concealment. A computer generated list of random number will be used. Receptionists dispense either non-thrust manipulation or MET according to a computer generated randomization list includes the sequential numbers using an online randomization website (https://www.graphpad.com/quickcalcs/randomize1.cfm). Each number and it's allocate group will be written on a piece of paper and will be concealed in an opaque envelope. The receptionist will inform the treating therapist about patients’ allocation according to the selected index card.

Blinding (investigator's opinion)

Double blinded

Blinding description

As mentioned above, the study will be double-blinded. In this way, the participants do not know in which group they are. Another physiotherapist will do the baseline and post-treatment evaluations without knowing which patients belonged to which groups (assessor-blinded).The data analyzer is also unaware of which study group the data belongs to.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of Tehran University of Medical Sciences

Street address

Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St, Keshavarz Blvd.

City

Tehran

Province

Tehran

Postal code

1417653761
Approval date: 2021-09-26, 1400/07/04
Ethics committee reference number: IR.TUMS.MEDICINE.REC.1400.728

Health conditions studied

1

Description of health condition studied: Knee Osteoarthritis
ICD-10 code: M17.1
ICD-10 code description: Unilateral primary osteoarthritis of knee

Primary outcomes

1

Description: Pain Intensity (at rest)
Timepoint: Before intervention- After the 10th intervention session (last session).
Method of measurement: Visual Analogue Scale

2

Description: Pain Intensity (during activities)
Timepoint: Before intervention- After the 10th intervention session (last session).
Method of measurement: Visual Analogue Scale

3

Description: Knee Extension Lack
Timepoint: Before intervention- After the 10th intervention session (last session).
Method of measurement: Passive Knee Extension Test by using Goniometer.

4

Description: Functional impairment
Timepoint: Before intervention- After the 10th intervention session (last session).
Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Secondary outcomes

1

Description: Distance Covered
Timepoint: Before intervention- After the 10th intervention session (last session).
Method of measurement: Six Minutes Walking Test (6MWT)

2

Description: Chair Stand Repetition
Timepoint: Before intervention- After the 10th intervention session (last session).
Method of measurement: 30 Seconds Chair Stand Test (30CST)

3

Description: Knee Mal-alignment
Timepoint: Before intervention- After the 10th intervention session (last session).
Method of measurement: Tibio-Femoral Angle (TFA) by using Goniometer.

Intervention groups

1

Description: Intervention group: Group A: will receive non-thrust manipulation supplemented with supervised exercises and TENS program at the clinic (three times a week), consisting of 10 sessions of approximately 50 min. Non thrust manipulation included Tibiofemoral Distraction, Anterior glide, Posterior glide of the tibia on the femur with grades II and III will be applied with the knee in slight flexion supported with using a pillow and Patellofemoral Joint glide in all directions based on the observation that in patients with patellofemoral joint osteoarthritis. This will be given for three repetitions of 1 minute each with a 30 second break between each repetition. Each direction will be repeated two times.
Category: Rehabilitation

2

Description: Intervention group: Group B: Contract–relax agonist contract (CRAC) which is one of muscle energy techniques will be used in this study supplemented with supervised exercises and electrical stimulation at the clinic (three times a week), consisting of 10 sessions of approximately 50 min.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Tehran University of Medical Sciences

Full name of responsible person

Sara Fereydounnia

Street address

corner of Ghods Street, Boulevard

City

Tehran

Province

Tehran

Postal code

۱۴۱۷۶۵۳۷۶۱

Phone

+98 21 7752 8468

Email

s-fereydounnia@sina.tums.ac.ir

1

Sponsor: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Akbar Fotouhi

Street address

Vice Chancellor for Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard

City

Tehran

Province

Tehran

Postal code

۱۴۱۷۶۵۳۷۶۱

Phone

+98 21 8163 3639

Email

research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Tehran University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Sara Fereydounnia

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

School of Rehabilitation, Piche- Shemiran, Enghelab Street

City

Tehran

Province

Tehran

Postal code

1148965111

Phone

+98 21 7752 8468

Fax

Email

S-fereydounnia@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Azadeh Shadmehr

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

School of Rehabilitation, Piche- Shemiran, Enghelab Street

City

Tehran

Province

Tehran

Postal code

1148965111

Phone

+98 21 7752 8468

Fax

Email

Shadmehr@tums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Sara Fereydounnia

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

School of Rehabilitation, Piche- Shemiran, Enghelab Street

City

Tehran

Province

Tehran

Postal code

1148965111

Phone

+98 21 7752 8468

Fax

Email

S-fereydounnia@sina.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document: All data is potentially shareable after unidentified individuals.
When the data will become available and for how long: Access period starts 3 months after the articles are published.
To whom data/document is available: For researchers working in academic, scientific and hospital institutions and clinicians.
Under which criteria data/document could be used: Researchers working in the field of musculoskeletal disorders rehabilitation and manual therapies.
From where data/document is obtainable: Applicants for documentation can contact Dr. Sara Fereydoonnia via email. S-fereydounnia@sina.tums.ac.ir
What processes are involved for a request to access data/document: Once they have the necessary criteria, the information will be provided to them within a month.
Comments

Comparison of the Non-thrust Manipulation VS. Muscle Energy Techniques in the Management of Patients with Knee Osteoarthritis: A Randomized Clinical Trial.