IRCT | Effects of muscle energy techniques versus corrective exercise programme on pain, range of motion and function in patients with upper cross syndrome: A randomized clinical trial.

Protocol summary

Study aim: To compare the effects of Muscle energy techniques with Corrective exercise programme on pain, range of motion, function.
Design: Randomized Clinical Trial
Settings and conduct: Department of Physiotherapy, University of Lahore Teaching Hospital, Lahore.
Participants/Inclusion and exclusion criteria: Neck disability index (NDI)score > 30 % (Mild to Moderate disability). Patients diagnosed with upper cross syndrome and having neck pain (Pain intensity on Visual Analogue Scale (VAS) > 3)/History of surgery or fracture or joint diseases of the spine Osteoporosis, Acute rheumatoid arthritis, Blood diseases
Intervention groups: Group A: Patients in group A will be treated with routine physiotherapy program (30 minutes) combined with muscle energy techniques (METS) (30 minutes) three sessions per week for 8 weeks. Group B: Patients in group B will be treated with routine physiotherapy program (30 minutes) combined with National Academy of Sports Medicine (NASM) based protocol (30 minutes) three sessions per week for 8 weeks.
Main outcome variables: Visual analogue scale Intensity or severity of pain will be measured through Visual analogue scale. Inclinometer Cervical range of motion will be measured through inclinometer. Neck disability index (NDI) To determine the extent of disability and activity limitations due to neck pain and disability, the Neck Disability Index (NDI) will be used.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20210816052201N1

Registration date: 2021-09-06, 1400/06/15

Registration timing: registered_while_recruiting

Last update: 2021-09-06, 1400/06/15

Update count: 0
Registration date: 2021-09-06, 1400/06/15

Registrant information: Name

Sana Akram

Name of organization / entity

The University of Lahore, Lahore Pakistan

Country

Pakistan

Phone

+92 42 35183083

Email address

sana.akram@uipt.uol.edu.pk

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2021-06-19, 1400/03/29
Expected recruitment end date: 2021-09-14, 1400/06/23
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Effects of muscle energy techniques versus corrective exercise programme on pain, range of motion and function in patients with upper cross syndrome: A randomized clinical trial.

Public title: Effects of muscle energy techniques versus corrective exercise programme on pain, range of motion and function in patients with upper cross syndrome: A randomized clinical trial.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

NDI score > 30 % (Mild to Moderate disability) Patients diagnosed with upper cross syndrome neck pain (Pain intensity VAS intensity > 3) from minimum 4 to 12 weeks

Exclusion criteria:

History of surgery or fracture or joint diseases of the spine Osteoporosis Acute rheumatoid arthritis Congestive heart failure Blood diseases Malignancy Severe skin sensitization mental illness Frozen Shoulder
Age: From 20 years old to 35 years old
Gender: Both

Phase

2-3

Groups that have been masked

Outcome assessor

Sample size

Target sample size: 50

Randomization (investigator's opinion)

Randomized

Randomization description

Patients will be randomly allocated in two experimental groups by computer generated table number. After randomization, opaque sealed envelope will be offered to the patients. The treatment will be provided according to the group mention on the envelope. Group A will be treated with routine physiotherapy program combined with muscle energy techniques (METS) Group B will be treated with routine physiotherapy program combined with National Academy of Sports Medicine (NASM) based protocol.

Blinding (investigator's opinion)

Single blinded

Blinding description

A single blinded randomized clinical trial study will be carried out on patients having neck pain secondary to upper cross syndrome. Patients will be recruited from Department of Physiotherapy, University of Lahore Teaching Hospital, Lahore. They will be assessed on selection criteria and eligible participants will be randomly allocated into two groups, using sealed enveloped method. Patients will be treated three times a week for total 8 weeks. After allocation in groups, participants will be assessed at baseline. Afterwards data will be collected at 4-week intervals until the conclusion of 8-week of interventions. For assessing long term effects of treatment protocol patients will be reassessed at 4-week interval after last treatment session. All assessments will be performed by the same assessor at all stages of data collection for all patients.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of University of Lahore(Institutional Review Board)

Street address

UNIVERSITY OF LAHORE

City

LAHORE

Postal code

54000
Approval date: 2021-06-17, 1400/03/27
Ethics committee reference number: 883

Health conditions studied

1

Description of health condition studied: Upper Cross Syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Pain, Neck Disability, Cervical Range Of Motion
Timepoint: Patients will be treated three times a week for total 8 weeks. After allocation in groups, participants will be assessed at baseline and comparability will be checked. Afterwards data will be collected at 4-week intervals until the conclusion of 8-week of interventions. For assessing long term effects of treatment protocol patients will be reassessed at 4-week interval after last treatment session. All assessments will be performed by the same assessor at all stages of data collection for all patients
Method of measurement: Visual analogue scale for Pain, Cervical range of motion will be measured through inclinometer, Function will be measured by the Neck Disability Index (NDI)

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: 1( Routine physical therapy + Muscle Energy Techniques)
Category: Treatment - Other

2

Description: Intervention group: (Routine physical therapy + National Academy of Sports Medicine (NASM) based exercise programme)
Category: Treatment - Other

Recruitment centers

1

Recruitment center: Name of recruitment center

The university of Lahore Teaching Hospital

Full name of responsible person

SANA AKRAM

Street address

UNIVERSITY OF LAHORE

City

LAHORE

Postal code

54000

Phone

+92 42 32560865

Email

sana.akrampt@gmail.com

1

Sponsor: Name of organization / entity

The University of Lahore

Full name of responsible person

Professor Dr. Ashfaq Ahmed

Street address

UNIVERSITY OF LAHORE

City

LAHORE

Postal code

54000

Phone

+92 42 32560865

Email

ashfaq.ahmad@uipt.uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: The University of Lahore
Proportion provided by this source: 100
Public or private sector: Private
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

University of Lahore

Full name of responsible person

Professor Dr. Ashfaq Ahmed

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

UNIVERSITY OF LAHORE

City

LAHORE

Province

PUNJAB

Postal code

54000

Phone

+92 42 35183083

Email

ashfaq.ahmad@uipt.uol.edu.pk

Person responsible for scientific inquiries

Contact: Name of organization / entity

The University of Lahore, Lahore Pakistan

Full name of responsible person

Profesor Dr. Ashfaq Ahmed

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

UNIVERSITY OF LAHORE

City

LAHORE

Province

PUNJAB

Postal code

54000

Phone

+92 42 35183083

Fax

Email

ashfaq.ahmad@uipt.uol.edu.pk

Person responsible for updating data

Contact: Name of organization / entity

The University of Lahore, Lahore Pakistan

Full name of responsible person

Arooj Hanif

Position

Investigator

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

UNIVERSITY OF LAHORE

City

LAHORE

Province

PUNJAB

Postal code

54000

Phone

+92 42 111 865 865

Fax

Email

arooj.hanif@uipt.uol.edu.pk

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is 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
Title and more details about the data/document: EFFECTS OF MUSCLE ENERGY TECHNIQUES VERSUS CORRECTIVE EXERCISE PROGRAMME ON PAIN, RANGE OF MOTION AND FUNCTION IN PATIENTS WITH UPPER CROSS SYNDROME: A RANDOMIZED CLINICAL TRIAL
When the data will become available and for how long: After publication of article the data will be available
To whom data/document is available: The data will be available to all kinds of Academic researchers.
Under which criteria data/document could be used: A request can be processed by the study sponsor or by a delegate of the sponsor (e.g., an academic institution).
From where data/document is obtainable: Applicant must contact cores ponder of a research through email address
What processes are involved for a request to access data/document: Applicant must contact cores ponder of a research through email address
Comments

Effects of muscle energy techniques versus corrective exercise programme on pain, range of motion and function in patients with upper cross syndrome: A randomized clinical trial.