The effectiveness of manual and TECAR therapy simultaneously versus manual therapy alone on pain, range of motion and disability in female with non-specific chronic neck pain
Determining and comparing the effect of manual therapy and concurrent therapy in comparison with manual therapy alone on pain, range of motion and disability in women with chronic non-specific neck pain
Design
A clinical trial with two treatment groups, single blind, randomized on a number of patients identified by initial sampling and G Power software. Random blocking method and random allocation software are used for randomization.
Settings and conduct
With accessible sampling method, women with NSCNP are entered into the study and randomly divided into two groups. One group receives 15 minutes of manual and simultaneous therapy simultaneously and the other group receives only manual therapy. All sessions of the present study, including initial clinical evaluations and treatment sessions are performed in physiotherapy clinics of Iran University of Medical Sciences.The evaluator in this experiment is blind.
Participants/Inclusion and exclusion criteria
Literate women with chronic nonspecific neck pain with or without referral to the upper extremity for no known cause lasting more than 3 months.
Intervention groups
There are two types of intervention: manual therapy that is performe for both groups and TECAR therapy that is apply simultaneously with manual therapy in only one group.
Main outcome variables
Pain; range of motion of neck; neck disability index; pain scale and neck disability
General information
Reason for update
Acronym
TECAR
IRCT registration information
IRCT registration number:IRCT20201112049366N1
Registration date:2020-12-28, 1399/10/08
Registration timing:prospective
Last update:2020-12-28, 1399/10/08
Update count:0
Registration date
2020-12-28, 1399/10/08
Registrant information
Name
Atena Bameri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3894 2465
Email address
bameria4047@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-04-18, 1400/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of manual and TECAR therapy simultaneously versus manual therapy alone on pain, range of motion and disability in female with non-specific chronic neck pain
Public title
the effectiveness of manual and TECAR therapy in neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Wemen with chronic nonspecific neck pain with or without referral to the upper extremity for no known reason that the duration of pain is more than 3 months
Age 20- 35 years old
Ability to read and write in Persian
Exclusion criteria:
Existence of neck pain symptoms of known origin such as disc herniation, spinal canal stenosis, instability in the spine
Known history of migraine
Existence of peripheral nerve involvement in the neck and shoulders
History of spinal fractures
History of spinal tumor
Presence of musculoskeletal disorders of the shoulder such as tendinitis, bursitis
History of inflammatory rheumatoid diseases
Pregnancy
Receive any type of physiotherapy treatment in the past month
People's unwillingness to participate in the study
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into experimental and control groups based on random blocking method (block size of 4 and allocation ratio of 1: 1). Thus, at the end of all four sampling, the number of samples in both groups is equal. The arrangement of blocks is done based on Random allocation software by a statistician.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the evaluator is blind in all four stages of evaluation: before treatment, end of the first week, end of the second week and one month after treatment.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, individuals are divided into two treatment groups, one group receiving TECAR therapy and manual therapy simultaneously and the other group receiving only manual therapy.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Before the intervention, the end of the first week and the end of the second week and one month after treatment
Method of measurement
Visual Analogue Scale
2
Description
Neck disability index
Timepoint
Before the intervention, the end of the first week and the end of the second week and one month after treatment
Method of measurement
Neck Disability Index Questionnaire
3
Description
Neck pain and disability scale
Timepoint
Before the intervention, the end of the first week and the end of the second week and one month after treatment
Method of measurement
Neck pain and disability scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use TECAR therapy and manual therapy simultaneously for 15 minutes and 10 sessions over two weeks. Manual treatment is performed simultaneously with the use of a special applicator device, simultaneously with TECAR therapy.
Category
Treatment - Devices
2
Description
Intervention group: TECAR therapy with TECAR therapy device for 15 minutes and 10 sessions over two weeks
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic of Iran University of Medical Sciences