IRCT | Investigating the effectiveness of Integrated Neuromuscular Inhibition technique on pain, function, grip strength and muscles activity in patients with lateral epicondylitis.

Protocol summary

Study aim: Determining the effectiveness of Integrated Neuromuscular Inhibition Technique on pain, function, grip strength, and muscle activity in patients with lateral epicondylitis.
Design: Clinical trial includes two groups of intervention and control, one blinded , Randomization in the form of permutation blocks.
Settings and conduct: This trial will be conducted at Zahedan University of Medical Sciences. Patients are blinded to the treatment. Patients are explained about the study. After obtaining informed consent, randomization will be performed. The initial size of the variables will be recorded. Individuals in each group will receive the treatment three times a week, for 4 continuous weeks, and at the end, the variables are recorded again.
Participants/Inclusion and exclusion criteria: Inclusion : Age between 18 to 60 years. Pain intensity at the initial visit should be at least 3. Unilateral elbow pain lasting more than 3 months. Tenderness near or on the lateral epicondyle. Positive 3 of the following 4 test: Grip strength, Cozen, Mill, Maudsley. No cardiovascular disease. No neurological disease. No neuromuscular disease or nerve entrapment. No history of trauma to the lateral epicondyle. No history of previous surgery. No other treatment in the last 6 months. Exclusion : No willingness to receive manual therapy. Failure to complete treatment sessions. Exacerbation of symptoms or patient dissatisfaction with the continuation of sessions.
Intervention groups: 1- Intervention group: In addition to routine treatment, also receives Integrated Neuromuscular Inhibition Technique(INIT); it includes several manual treatments (ischemic pressure, strain-counterstrain, and muscle energy technique). 2- Control group: only received routine physiotherapy treatments; included: hot pack, TENS, ultrasound, education and exercises.
Main outcome variables: Pain; Disability; Grip strength; Muscle activity.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20220626055278N3

Registration date: 2025-05-05, 1404/02/15

Registration timing: prospective

Last update: 2025-05-05, 1404/02/15

Update count: 0
Registration date: 2025-05-05, 1404/02/15

Registrant information: Name

Hassan Namvar

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 54 3344 6819

Email address

hassan_753@zaums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2025-05-22, 1404/03/01
Expected recruitment end date: 2025-07-23, 1404/05/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Investigating the effectiveness of Integrated Neuromuscular Inhibition technique on pain, function, grip strength and muscles activity in patients with lateral epicondylitis.

Public title: Investigating the effectiveness of Integrated Neuromuscular Inhibition technique in patients with lateral elbow pain.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Age between 18 to 60 years. The patient's pain intensity at the initial visit should be at least 3 on the Visual Analog scale. Unilateral elbow pain that lasts more than 3 months. Tenderness near or over the lateral epicondyle. Positive results in 3 of the following 4 tests to confirm epicondylitis: grip strength test, Cozen test, Mill test, Maudsley test. Absence of cardiovascular disease. Absence of neurological diseases. Absence of neuromuscular diseases and nerve entrapments. No history of trauma to the lateral epicondyle. No history of previous surgery. No other treatment received in the last 6 months.

Exclusion criteria:

Failure to complete treatment sessions. Exacerbation of symptoms or patient dissatisfaction with the continuation of treatment sessions.
Age: From 18 years old to 60 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant

Sample size

Target sample size: 40

Randomization (investigator's opinion)

Randomized

Randomization description

Sampling will be easy and accessible, taking into account the characteristics of the entry. A permutation block randomization method will be used to assign individuals to groups. Initially, individuals will be randomly divided into four equal blocks by drawing lots and numbered. Then, the block numbers are randomly selected by a person who is not involved in the sampling process so that the blocks are placed in two different treatment groups, respectively, until the groups reach the desired sample size.

Blinding (investigator's opinion)

Single blinded

Blinding description

Patients will be unaware of the grouping. Physiotherapy modalities are explained to the patients and they are told that modalities and manual therapy are used in their treatment, but they will be unaware of what aproach are used in each group.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Zahedan University of Medical Sciences.

Street address

Dr. Hesabi Square, Imam Hossein Blvd, compus of university of medical sciences.

City

Zahedan

Province

Sistan-va-Balouchestan

Postal code

9816743463
Approval date: 2025-04-13, 1404/01/24
Ethics committee reference number: IR.ZAUMS.REC.1404.025

Health conditions studied

1

Description of health condition studied: lateral epicondylitis
ICD-10 code: M77.1
ICD-10 code description: Lateral epicondylitis

Primary outcomes

1

Description: Pain that is more than 3 or 3 befor intervention.
Timepoint: Measurement befor the start of the intervention and 4 weeks after the application of the intervention.
Method of measurement: Visual Analoge Scale.

2

Description: Function.
Timepoint: Measurement befor the start of the intervention and 4 weeks after the application of the intervention.
Method of measurement: Patient Rated Tennis Elbow Evaluation Questionnaire.

3

Description: Grip strength.
Timepoint: Measurement befor the start of the intervention and 4 weeks after the application of the intervention.
Method of measurement: Dynamometer device.

4

Description: Muscle activity.
Timepoint: Measurement befor the start of the intervention and 4 weeks after the application of the intervention.
Method of measurement: Surface Electromyography Device.

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: includes Integrated Neuromuscular Inhibition Techniques with routine physiotherapy. This technique includes several different manual therapies:Ischemic pressure, Strain CounterStrain, and Muscle energy techniques. After finding tender point at the lateral epicondyle, pressure is applied for 90 seconds, then the patient is given a rest, and this procedure is repeated 3 times. To perform the strain-contrastrain technique, we move the patient's wrist to a position that reduces the patient's pain by at least 70 percent, maintain pressure in this position for 90 seconds, and repeat this process 3 times. To perform the Muscle Energy Technique, we bend the patient's wrist slightly and obtain a resistive contraction in the direction of wrist extension from the patient. Hold the contraction for 7 seconds and then rest. During the rest period, the wrist is further flexed and this process is repeated 3 times. Finally, a soft tissue extensor stretch is performed for 30 seconds.
Category: Rehabilitation

2

Description: Control group: This group only received routine physiotherapy treatments, including: hot packs, transcutaneous electrical nerve stimulation, ultrasound, education and exercises. The hot pack is placed on the epicondyle for 20 minutes. Transcutaneous electrical nerve stimulation with frequency of 60 Hertz and pulse duration of 100 milliseconds and tolerable intensity of 10 to 30 milliamps for 20 minutes, will be applied through two electrodes that we are placing on the extensor origion muscle of the patient. Ultrasound waves with frequency of 1 MHz and an intensity of 1.5 watts/cm2 are applied around the lateral epicondyle for 3-5 minutes. Transcutaneous electrical nerve stimulation and ultrasonic waves will be performed by devices manufactured by Novin Medical Engineering company. Patient education includes avoiding lifting, repetitive wrist activities, using screwdrivers and mice, and any activity that aggravates pain. The patient's exercises include 3 groups: 1- Stretching of the wrist extensors and flexors, each stretch should be maintained for 30 seconds and repeated 3 times. 2- Active flexion and extension movements of the patient's wrist and elbow, each movement includes 3 sets and each set has 20 repetitions. 3- Isometric grip and wrist extension movements, each contraction should be maintained for 20 seconds and has 20 repetitions.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Razmjoomoghadam Physiotherapy Clinic

Full name of responsible person

Maryam Sargolzehi

Street address

Ayatollah kafami St., Shahid Rajmjoomoghadam Comprehensive Center, Physiotherapy Clinic

City

Zahedan

Province

Sistan-va-Balouchestan

Postal code

9813664855

Phone

+98 54 3321 7006

Email

sargolzaei_pt@yahoo.com

1

Sponsor: Name of organization / entity

Zahedan University of Medical Sciences

Full name of responsible person

Ebrahim Kord

Street address

Dr. Hesabi Square, Imam Hossein Blvd, Campus of University of Medical Sciences

City

Zahedan

Province

Sistan-va-Balouchestan

Postal code

9816743463

Phone

+98 54 3337 2114

Email

hassan_753@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Zahedan 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

Zahedan University of Medical Sciences

Full name of responsible person

Arezu Naseri

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

No.7 , Nasrin 9 St., Gaffari Ave

City

Birjand

Province

South Khorasan

Postal code

9717916819

Phone

+98 56 3223 6047

Email

arezunaseri98@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Zahedan University of Medical Sciences

Full name of responsible person

Hassan Namvar

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Modares St., next to medical imaging, Namvaran Doctors Building, Atieh Physiotherapy

City

Zahedan

Province

Sistan-va-Balouchestan

Postal code

9816677389

Phone

+98 54 3344 6819

Email

hassan_753@zaums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Zahedan University of Medical Sciences

Full name of responsible person

Arezu Naseri

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

No.7, Nasrin 9 st., Ghaffari Ave.

City

Birjand

Province

South Khorasan

Postal code

9717916819

Phone

+98 56 3223 6047

Email

arezunasri98@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Investigating the effectiveness of Integrated Neuromuscular Inhibition technique on pain, function, grip strength and muscles activity in patients with lateral epicondylitis.