- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06437483
Effects of Sustained Natural Apophyseal Glides Combined With Kinesiotaping in Patients With Chronic Mechanical Neck Pain: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to determine the combined effects of sustained natural apophyseal glides and kinesiotaping in chronic mechanical neck pain patients of age range 18-40. Outcome variables are pain, range of motion and functional disability of neck which will be determined by using the following respective data collection tools:
- Numeric pain rating scale
- Inclinometer
- Neck Disability Index
Participants of interest will be approached and explained about the research. They will be randomly allocated in to two groups. Informed written consent will be taken. The intervention protocol will be comprised of six sessions over a 2-week period (3 sessions per week on alternate days). Outcome measures will be assessed at baseline and after 2 weeks. Data will be analyzed and interpreted using SPSS.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fatima Riaz, MS-MSKPT
- Phone Number: 0347-0051283
- Email: fatimah.riazf16@gmail.com
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 460000
- Recruiting
- Foundation University College of Physical Therapy
-
Contact:
- Ali Bin Asim, MS-OMPT
- Phone Number: 03135088144
- Email: ali.asim@fui.edu.pk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mechanical Neck Pain
- Age range: 18-40 years
- Both males and females
- Having pain from at least last 3 months (chronic)
- Pain score greater than 3 on NPRS
- Pain and limitation on neck moverment
Exclusion criteria :
- Recent surgery of spine, Temporomandibular joint or shoulder in the previous 12 months.
- Open wound around neck.
- History of traumatic injuries or fractures in the cervical spine.
- History of neurological and cardiac pathologies.
- History of some serious pathologies (e.g., malignancy, inflammatory disorder etc.).
- History of cervical or shoulder neurological movement disorder.
- Cervical spondylolisthesis, cervical radiculopathy, and spinal stenosis.
- Vascular syndromes such as basilar insufficiency.
- Diagnosed psychiatric disorders such as anxiety and depression.
- Interventions including medications, exercise or physical therapy in the last 3 months.
- Any other condition that contraindicates kinesiotaping such as skin sensitivity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Participants in this group will receive Sustained Natural Apophyseal Glides followed by Kinesiotaping in addition to the conventional treatment.
This arm of the study will assess the synergistic effects of SNAGs and kinesiotape.
|
SNAGs: Therapist will apply an antero-superior accessory glide to the superior spinous process of the involved motion segment (between C3 to C7) by pushing it towards the direction of eyeball at approximately a 45 degree angle, using the thumb. The other thumb will reinforce the glide. Painless accessory glide will be maintained and subject will slowly turn their head towards the painful or restricted side (that elicited symptoms) and sustain the position for a few seconds. In case of symptom-free, the subject will apply overpressure at the end of restricted range of motion. The glide will be maintained till the head returns to the midline. Each session will consist of three sets of six to ten repetitions. Kinesiotaping (KT): Subject will be in comfortable sitting position. Neck of the subject will be thoroughly cleaned with alcohol and sterile gauze pads before the application of Kinesiotape.The layers of KT will be applied in the form of two strips i.e. "Y strip" and "I strip". and applied over the neck in a position of cervical flexion and contralateral rotation and, pasted up and over either ridge of the spine covering the cervical muscles.It extends from T1-T2 to either side of C1-C2.The second layer is I-strip:The overlaying I-strip will be placed perpendicular to the Y-strip, It will be stretched from the both ends, and the middle portion of the tape will be applied first after which tension is released and ends are applied without tension.
Hot pack (moist heat) and TENS will be applied, each for 10 minutes.
|
|
Active Comparator: Group B
Participants in group B will receive Sustained Natural Apophyseal Glides along with the conventional treatment.
|
SNAGs: Therapist will apply an antero-superior accessory glide to the superior spinous process of the involved motion segment (between C3 to C7) by pushing it towards the direction of eyeball at approximately a 45 degree angle, using the thumb. The other thumb will reinforce the glide. Painless accessory glide will be maintained and subject will slowly turn their head towards the painful or restricted side (that elicited symptoms) and sustain the position for a few seconds. In case of symptom-free, the subject will apply overpressure at the end of restricted range of motion. The glide will be maintained till the head returns to the midline. Each session will consist of three sets of six to ten repetitions.
Hot pack (moist heat) and TENS will be applied, each for 10 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 2 weeks
|
It will be documented by using Numeric Pain Rating Scale (NPRS) which is a self- rated scale of 0-10 points where the participants rate their pain verbally or in writing."0"
shows no pain whereas "10" represents worst pain.
According to guidelines, NPRS scale categorizes pain into no pain (0), mild pain (1-3), moderate pain (4-7) and severe pain (8-10).
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2 weeks
|
|
Cervical Range of Motion
Time Frame: 2 weeks
|
The range of motion for flexion, extension, and side bending will be documented using a Inclinometer, positioned on the vertex of the head.
For rotation, it will be placed on the forehead.
Inclinometer demonstrates good Intraclass Correlation Coeffecient (ICC) value of 0.770-0.982.
|
2 weeks
|
|
Functional Disability of Neck
Time Frame: 2 weeks
|
It will be documented by using Neck Disability Index (NDI) which consists of 10 questions addressing various aspects of neck functions to assess the impact of neck pain on a person's daily life.
A total score ranges between 0 and 50 with higher scores indicating a high level of disability.
Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability).
All sections are then totaled.The scores on NDI are typically classified as: 0-4 (no disability), 5-14 (mild disability), 15-24 (moderate disability), 25-34 (severe disability), above 34 (complete disability).
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2 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2024/7
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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