Protocol summary
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Study aim
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To check and compare the effects of PNF (Hold Relax) and METs (Post isometric relaxation) on cervical pain, cervical range of motion and neck disability in non-specific neck pain
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Design
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It will be a single blinded Randomized Clinical trial. Study population is patients suffering with non specific neck from 3 to 12 months. A total of 32 participants will be recruited according to the criteria. Lottery method will be used for the recruitment of patients in two equal groups.
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Settings and conduct
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Study setting :
1. Madina Teaching Hospital Faisalabad
2. DHQ Hospital Faisalabad
3. Allied Hospital Faisalabad;
City : Faisalabad, Pakistan;
Study Population: Patients suffering with non-specific neck pain from 3 months to 12 years and NDI score greater than 10%;
Blinding: it will be a single blinded study and Lottery method will be used for the recruitment of patients in two equal groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Patients that fulfill diagnostic criteria of non-specific neck pain;
Mild to moderate intensity pain on VAS;
Neck symptoms from 3 months to 1 year;
Age between 20 to 35 years;
Gender male and females;
Neck disability index score more than 10%.
Exclusion Criteria:
Patients with history of neck pain due to Metabolic disorders (i.e. osteoporosis, Paget’s disease, osteomalacia);
Patients with history of neck pain due to neurological disorders;
Patients with history of malignancy or infections;
Patients with any history of any neck trauma or fractures;
Patients with congenital neck deformities (i.e. torticollis);
Patients with known psychological disorder;
Patients not willing to take part in research
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Intervention groups
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Intervention group A = Baseline treatment and Hold relax technique of PNF;
Intervention group B = Baseline and Post-isometric relaxation of METs
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Main outcome variables
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Neck pain;
Cervical range of motion;
Neck disability index
General information
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Reason for update
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To update any missing information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220930056062N1
Registration date:
2022-10-15, 1401/07/23
Registration timing:
prospective
Last update:
2023-06-12, 1402/03/22
Update count:
1
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Registration date
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2022-10-15, 1401/07/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-10-16, 1401/07/24
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Expected recruitment end date
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2022-12-15, 1401/09/24
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the effects of proprioceptive neuromuscular facilitation (hold relax) and muscle energy technique (post isometric relaxation) in non-specific neck pain.
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Public title
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Effects of Hold relax and Post isometric relaxation techniques in non-specific neck pain.
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients that fulfill diagnostic criteria of non-specific neck pain
Mild to moderate intensity pain on VAS
Neck symptoms from 3 months to 1 year
Age between 20 to 35 years
Both gender (male and female)
Neck disability index score more than 10%
Exclusion criteria:
Patients with history of neck pain due to Metabolic disorders (i.e. osteoporosis, Paget’s disease, osteomalacia)
Patients with history of neck pain due to neurological disorders
Patients with history of malignancy or infections
Patients with any history of any neck trauma or fractures
Patients with congenital neck deformities (i.e. torticollis)
Patients with known psychological disorder
Patients not willing to take part in research
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Age
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From 20 years old to 35 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
32
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants will be screened according to the criteria and 32 participants who met the inclusion criteria of the study will be selected. Participants will be divided randomly into 2 treatment groups, 16 each, by using the lottery method. Each participants will be asked to choose between two pieces of paper, with group A and group B written on them. Participants will be allocated into treatment groups according to the piece of paper they will choose. After completing 16 participants in one group, all other participants will be assigned to the other treatment group, so that both treatment groups have equal participants.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Each participants will be asked to choose between two pieces of paper, with group A and group B written on them. Participants will be allocated into treatment groups according to the piece of paper they choose. The patients will not know, in which group he/she is enrolled to avoid bias.
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-03-03, 1401/12/12
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Ethics committee reference number
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TUF/IRB/164/2023
Health conditions studied
1
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Description of health condition studied
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Non specific neck pain
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ICD-10 code
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M54.2
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ICD-10 code description
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Cervicalgia
Primary outcomes
1
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Description
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Neck pain
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Timepoint
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Neck pain will be measured three times. Before the start of 1st session, after 2 weeks (6 sessions) and third time after 4 weeks (12 sessions).
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Method of measurement
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Visual analogue scale
2
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Description
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Cervical Range of motion
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Timepoint
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Cervical range of motion will be measured three times. Before the start of 1st session, after 2 weeks (6 sessions) and third time after 4 weeks (12 sessions).
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Method of measurement
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Universal goniometer
3
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Description
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Neck disability
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Timepoint
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Neck disability will be measured three times. Before the start of 1st session, after 2 weeks (6 sessions) and third time after 4 weeks (12 sessions).
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Method of measurement
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Neck disability index
Intervention groups
1
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Description
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Intervention group A will receive 3 sessions of Hold relax per week for 4 weeks. This manual Technique will applied on 3 muscle sternocleidomastoid, Levator scapulae and upper trapezius muscle. In one session 3 repetitions will be performed.
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Category
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Treatment - Other
2
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Description
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Intervention group B will receive 3 sessions of Post isometric relaxation technique per week for 4 weeks. This manual Technique will applied on 3 muscle sternocleidomastoid, Levator scapulae and upper trapezius muscle. In one session 3 repetitions will be performed.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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All financial expenses are bear by myself
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available