To evaluate if pilates exercises have significant effects than neck-stabilization exercises in treating chronic neck pain, sleep disturbance as well as decreasing kinesiophobia in non-specific chronic neck pain patients
Design
Sixty participants will be randomly allocated into 2 groups , thirty in each group via computerized random number generator. Group 1 will receive neck stabilization exercises and Group 2 will receive Pilates exercises . The interventions will be given for 8 weeks
Settings and conduct
Sample will be selected through Convenient sampling technique from physiotherapy department of Allied Hospital, Faisalabad, Physical therapy department of DHQ Faisalabad
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Both gender
• Age 18-45 years .
• Recurrent history of neck pain from 3 months.
• Intensity of pain greater than or equal to 5/10 on numerical pain rating scale.
Exclusion criteria:
• History of cervical spine injury or surgery
• History of neck trauma , spinal deformity .
• History of specific neck pain such as fibromyalgia , Rheumatological diseases
• History of neck-pain secondary to other conditions including neoplasm, any neurological or vascular disease
• History of radiculopathy
• History of Degenerative arthritis of cervical spine
• History of osteoporosis
• History of low back pain
Intervention groups
Sixty participants will be randomly allocated into 2 groups , thirty in each group via computerized random number generator. Group 1 will receive neck stabilization exercises and Group 2 will receive Pilates exercises . The interventions will be given for 8 weeks
Main outcome variables
Numerical pain rating scale, Insomnia severity index and Tampas scale of kinesiophobia will be used for pre and post assessment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220930056062N7
Registration date:2024-06-24, 1403/04/04
Registration timing:prospective
Last update:2024-06-24, 1403/04/04
Update count:0
Registration date
2024-06-24, 1403/04/04
Registrant information
Name
Kaiynat Shafique
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 334 6925051
Email address
kaiynatshafique@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-26, 1403/04/06
Expected recruitment end date
2024-08-01, 1403/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Neck-stabilization exercises and Pilates exercise on pain, sleep disturbance, and kinesiophobia in Non-specific chronic neck pain
Public title
Neck-stabilization exercises vs Pilates exercise in non-specific chronic neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both gender
Age 18-45 years
Recurrent history of neck pain from 3 months
Intensity of pain greater than or equal to 5/10 on numerical pain rating scale
Exclusion criteria:
History of cervical spine injury or surgery
History of neck trauma , spinal deformity
History of specific neck pain such as fibromyalgia , Rheumatological diseases
History of neck-pain secondary to other conditions including neoplasm, any neurological or vascular disease
History of radiculopathy
History of Degenerative arthritis of cervical spine
History of osteoporosis
History of low back pain
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly allocated into 2 groups , thirty in each group via computerized random number generator.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be blind in this clinical trial.
In this single-blinded RCT study, participants will be unaware of which treatment they are receiving. To ensure blinding, the treatments will be somewhat similar. The allocation sequence will be concealed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Government College University Faisalabad
Street address
Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2024-06-14, 1403/03/25
Ethics committee reference number
GCUF/REF/26451
Health conditions studied
1
Description of health condition studied
Cervicalgia (Non-specific Neck pain)
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia
Primary outcomes
1
Description
Pain
Timepoint
The assessment will be made two times , before and after 8 weeks
Method of measurement
Numerical pain rating scale (NPRS)
2
Description
Sleep disturbance
Timepoint
The assessment will be made two times , before and after 8 weeks
Method of measurement
Insomnia severity index (ISI)
3
Description
Kinesiophobia
Timepoint
The assessment will be made two times , before and after 8 weeks
Method of measurement
Tampas scale of kinesiophobia
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: neck stabilization exercises (The interventions will be given 2 times per week for 8 weeks, 5 -10 repetitions, 30 minutes per session. Following exercises will include 1.Neutral head position 2.Shoulder blade stabilization 3.Chin tuck in 4.Cranio-cervical flexion 5.Cervical flexion - extension 6.Shoulder shrugging. )
Category
Rehabilitation
2
Description
Intervention group 2: Pilates exercises (The interventions will be given 2 times per week for 8 weeks, 5 -10 repetitions, 30 minutes per session. Following exercises will include 1. Hip twist level 1, 2. Rolling like a ball, 3. Shoulder bridge level 1, 4. The hundred level 1, 5. Breast stroke level 1, 6. Breast stroke level 2)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
DHQ Faisalabad
Full name of responsible person
Rafia Imtiaz
Street address
Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9210092
Email
rafiaimtiaz@gcuf.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Street address
Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9210023
Email
rafiaimtiaz@gcuf.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
It will be a self funded study
Proportion provided by this source
1
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9210023
Email
rafiaimtiaz@gcuf.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Position
Punjab
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200876
Email
rafiaimtiaz@gcuf.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Government College University
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200876
Email
rafiaimtiaz@gcuf.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD