A comparative study of the effectiveness of clinically-supervised and internet-based exercise therapy on pain, muscle thickness and endurance and head posture in females with chronic non-specific neck pain
Comparison of the effect of clinically-supervised and internet-based exercise therapy on pain, muscle thickness and endurance and forward head posture in female with chronic neck pain.
Design
Clinical trial, with a parallel control group, single-blind, randomized, will be performed on 44 women. Block randomization is performed.
Settings and conduct
This research will be performed in Hazrat Rasool Hospital. After signing the consent form, all female patients with neck pain are randomly divided into two groups; one group performs the exercises in the clinic and the second group performs the exercises online. Data are collected and analyzed in pre- and post-intervention evaluations.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Having non-specific chronic neck pain (persistent neck pain for at least three months and with an intensity of at least 3 according to VAS criteria).
female.
Age 65-18 years.
BMI < 30.
Balanced mood.
Having access to the Internet
Participant consent to participate in the trial.
exclusion criteria:
Existence of acute traumatic injury in the spine.
Existence of a history of surgery or previous lesion of the neck.
Pregnancy.
Simultaneous pain in the shoulder joint.
Fractures in the upper limbs over the past year.
Malignant tumors.
Inflammatory diseases
Any therapy for neck pain during the last three months.
Congenital spinal deformity.
Intervention groups
Intervention group 1: Supervised exercise therapy;
Intervention group 2: Internet-based exercise therapy.
The exercise protocol designed for patients is the same for all participants in both groups and includes a 6-week, 3 sessions per week, exercise therapy protocol. A specific group of exercise is designed for every 14 days.
Main outcome variables
neck pain; thickness of neck muscles; neck muscle endurance; head posture
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20181219042055N2
Registration date:2022-07-05, 1401/04/14
Registration timing:registered_while_recruiting
Last update:2022-07-05, 1401/04/14
Update count:0
Registration date
2022-07-05, 1401/04/14
Registrant information
Name
Sara Lotfian
Name of organization / entity
Shaheed Rajaee Heart Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2489
Email address
lotfiyan.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effectiveness of clinically-supervised and internet-based exercise therapy on pain, muscle thickness and endurance and head posture in females with chronic non-specific neck pain
Public title
Comparison of the effect of two methods of prescribing exercise on neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having non-specific chronic neck pain (persistent neck pain for at least three months and with an intensity of at least 3 according to VAS criteria)
female
Age 18- 65 years
Body mass index equal to or less than 30
Balanced mood
Ability to access the Internet and other communication tools
Consent to participate in the trial
Exclusion criteria:
Existence of acute traumatic injury in the spine approved by a specialist
Existence of a history of surgery or previous lesion of the neck and other joints of the upper limbs during a recent year
Pregnancy
Simultaneous pain in the shoulder joint
Existence of new fractures in the upper limbs during a recent year
Suffering from malignant tumors
Inflammatory diseases such as ankylosing spondylitis, rheumatoid arthritis, fibromyalgia, myelopathy and cervical radiculopathy
Participate in exercise therapy, manipulation, acupuncture and physiotherapy programs during the last three months
Congenital spinal deformity
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Eligible patients were randomized in blocks of four, into the following groups:
A: exercise therapy in clinic
B: online exercise therapy
Randomization tool: Random assignment in groups is done applying the website of "www.randomization.com" (seed 23226) and then in order of entering the study, the participant is allocated to one of the groups of A (supervised exercise therapy) or B (Internet-based exercise therapy) as arranged above.
The random sequence has been made online. For allocation concealment the above sequence is only at the disposal of the main researcher and the group assigned to each patient is determined by them after the participant has entered the study. In this study, in order for patients not to be informed about the other group's exercise therapy method, group A patients are treated on even days and group B patients are treated on odd days. It should be noted that the exercise therapy sessions are supervised by a sports medicine resident. Evaluations in hospital, before and after interventions, are performed by another resident who is unaware of the presence of patients in the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Of the three main groups involved in researches, including participants, administrators and evaluators, there is only the possibility of blinding for the group of evaluators in this study. As it is not feasible to blind participants to the method of prescribing exercise therapy, the patient is aware of it (in clinic or online).
The researcher who is in charge of prescribing and supervising the exercise therapy sessions also knows how people are assigned to different groups, and the researcher prescribes specific exercises to each participant.
The third group, i.e. evaluators, including the initial and outcome assessor, data analyzer, as well as the data and safety monitoring board, will not be informed of the method of exercise training in this study; and the data will be provided to them in groups of A and B.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine of Iran University of Medical Sciences
Street address
3th Floor of School of Medicine, Shahid Hemmat Highway (between Sheikh Fazlollah and Shahid Chamran Intersection)
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-11-28, 1400/09/07
Ethics committee reference number
IR.IUMS.FMD.REC.1400.506
Health conditions studied
1
Description of health condition studied
Chronic non-specific neck pain
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia
Primary outcomes
1
Description
Neck pain
Timepoint
Before and after the intervention (6 weeks)
Method of measurement
Visual analogue scale
2
Description
Thickness of neck muscles
Timepoint
Before and after the intervention (6 weeks)
Method of measurement
Ultrasound device
3
Description
Neck muscle endurance
Timepoint
Before and after the intervention (6 weeks)
Method of measurement
Cervical flexor and extensor muscles endurance tests
4
Description
Head posture
Timepoint
Before and after the intervention (6 weeks)
Method of measurement
measurement of craniovertebral angle
Secondary outcomes
1
Description
neck disability
Timepoint
Before and after treatment intervention (6 weeks later)
Method of measurement
Neck Disability Index Questionnaire
Intervention groups
1
Description
Intervention group 1: Exercise therapy under the supervision in the sports medicine clinic that includes 18 training sessions, 3 days a week for 6 weeks; and will be done in 3 different phases based on progressive increase of workload . Each phase lasts two weeks and at the end the second week, the exercises of the next phase is added. All sessions start with a warm-up in the form of walking and simultaneously moving the head and neck to the sides, flexion and extension, and rotating the neck to both sides. Step 1 (1-The participant, while sitting, tries to performed the chin tuck without raising her head and maintaining this position for 10 seconds. 2- The participant, while lying down in a supine position, places a towel in the form of a tube in the space between the neck and the table and try to squeeze the towel and maintain this position for 10 seconds). step 2 (1-The participant, lying in supine position, performs the chin tuck position then lifting the head off the table and holding it for 10 seconds. 2- The participant is placed on all fours and flex her head and look at their knees and hold for 10 seconds, then raise the head up to 30 degrees extension and stare at the point between the two hands and hold this position for 10 seconds). step 3 (1- Using an elastic band, while applying a force from back to front, the person moves the head to the extension position and holds for 10 seconds. 2- The person uses an elastic band while applying a force from the front of the head to back, moves the head to the flexion position and holds for 10 seconds) Each set includes 10 repetitions.
Category
Treatment - Other
2
Description
Intervention group 2: Internet-based exercise therapy that initially internet and mobile messaging applications access will be checked. For the IET group, exercise therapy guidelines with videos of how to perform exercises are made ready; the first phase of which will be delivered to them after pre-intervention evaluation. Each phase lasts two weeks and at the end of the second week, the exercises of the next phase is added. They will be asked to perform their exercise therapy protocol three days a week for six weeks (18 sessions totally) similar to the other group . If the patient has any questions about the exercises, she can ask online. The details and sequence of prescribing exercises are the same as in intervention group 1.