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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06437483
Other study ID # FUI/CTR/2024/7
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 10, 2023
Est. completion date June 30, 2024

Study information

Verified date May 2024
Source Foundation University Islamabad
Contact Fatima Riaz, MS-MSKPT
Phone 0347-0051283
Email fatimah.riazf16@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized controlled trial and its purpose is to determine the combined effects of sustained natural apophyseal glides and kinesiotaping on pain, range of motion and neck disability in patients with chronic mechanical neck pain.


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: 1. Numeric pain rating scale 2. Inclinometer 3. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date June 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Sustained Natural Apophyseal Glides
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
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.
Conventional Treatment
Hot pack (moist heat) and TENS will be applied, each for 10 minutes.

Locations

Country Name City State
Pakistan Foundation University College of Physical Therapy Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity 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). 2 weeks
Primary Cervical Range of Motion 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
Primary Functional Disability of Neck 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). 2 weeks
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