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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06241014
Other study ID # REC/RCR & AHS/23/0157
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 10, 2024
Est. completion date July 30, 2024

Study information

Verified date March 2024
Source Riphah International University
Contact Dr Ameena Amjad, MPhil
Phone 923234184526
Email ameena.uhs@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Neck pain is one of the common musculoskeletal problems. People with neck pain can have difficulties with daily activities and be limited in work and social participation. Main symptoms of people with neck pain include pain, decreased range of motion (ROM), muscle weakness and dysfunction. Common neck pain causes include degenerative disc disease, herniated disc disease, cervical radiculopathies, myofascial pain syndrome and viral infections. Muscular strains, postural and ergonomics are also related to neck pain and whiplash injuries. The onset of pain may be insidious or may follow trauma, and it may be recurrent or persistent in nature. Ideally, the pain goes away in 1-3 weeks, but in some cases it persists and become chronic neck pain. The aim of this study is to compare the effects of mulligan mobilization with and without sling exercises on pain, and disability in non-specific neck pain. Non-specific neck pain reduces range of motion which may be linked to mechanical restriction between two or more vertebrae and muscular spasm.


Description:

Participants who will meet the inclusion criteria will be recruited by convenience sampling technique and will be allocated to groups by simple randomization process by sealed opaque enveloped labeled as 1 for Group A and 2 for Group B. After taking consent from the participants with non-specific neck pain of both genders will be randomized into two equal groups. Subjects from physical therapy department will be assessed with neck disability index, goniometer and Numeric pain rating scale. At start of study, a formal educational session, lasting about 30 min will be given by physiotherapist. Group A: In this group, Subjects will be treated with Mulligan mobilizations along with sling exercises. Mulligan mobilizations include SNAGs. Participants will receive 3 sets of mulligan mobilization techniques per session, each set involving 10 times repetition of the exercise. The interval between the sets will be 15 to 20 seconds. The technique will be repeated total of six times having two sessions per week for 3 weeks. For the sling exercise, the sling exercise program will also be applied for 3 weeks, 2 times a week for 20 minutes per day. To perform the exercise, the subjects will be instructed with a demonstration and explanation. In supine position, the head will be supported by an inelastic sling and the therapist will hold the cervical vertebral portion softly with two hands. Therapist will pull the cervical vertebral portion and back of the head softly. The subjects will maintain this for 6-7 seconds and relax slowly. In the second technique, Subjects will be positioned in supine lying position with the cervical spine in a neutral position on the sling device. One hand of the therapist contacts and fixes the transverse process of C1 (both), while the other hand grabs the occiput and applies mobilization in the dorsal direction. Subjects in this group will be applied with passive mobilization for 3 min to the segment (occiput-C1). In the same posture the subjects will be instructed to perform a flexion motion at (occiput-C1). The therapist will guide the optimal segmental movement through the hand. This intervention will also be performed 3 times for 1 min, with an interval of 1 min. Similarly, In prone position the forehead will be placed on an inelastic sling. The therapist will hold the cervical vertebral portion with two hands softly. The therapist will pull the cervical vertebral portion toward the upper direction at the same time. The patient will maintain this for 6-7 seconds and relax slowly. Each movement will be repeated 10 times


Recruitment information / eligibility

Status Recruiting
Enrollment 46
Est. completion date July 30, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers No
Gender All
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria: - Age between 25-50 years. - Having neck pain for at least 2 weeks - Pain intensity of at least 2 on NPRS - Greater than or equal to 15 points on the neck disability index (NDI) - Having primary complaint of non-specific neck pain Exclusion Criteria: - History of Cervical surgery - Cervicogenic headache - Previous cervical spine surgery - Serious Spinal pathology (like tumor, infection, and dislocation) - Traumatic injuries (e.g., contusion, fracture, and whiplash injury) - Vascular diseases and Neurologic disorders (e.g., trigeminal neuralgia) - Concomitant medical diagnosis of any primary headache (vertigo, VBI or migraine) - And clinical diagnosis of cervical radiculopathy, Spinal stenosis or myelopathy.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mulligan Mobilization and Sling Exercises
Mulligan mobilizations along with sling exercises. Mulligan mobilizations include SNAGs. Participants will receive 3 sets of mulligan mobilization techniques per session, each set involving 10 times repetition of the exercise. The interval between the sets will be 15 to 20 seconds. The technique will be repeated total of six times having two sessions per week for 3 weeks. For the sling exercise, the sling exercise program will also be applied for 3 weeks, 2 times a week for 20 minutes per day. To perform the exercise, the subjects will be instructed with a demonstration and explanation.
Mulligan Mobilization
Mulligan Mobilization

Locations

Country Name City State
Pakistan Pro Care Health Clinic Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Buyukturan O, Buyukturan B, Sas S, Kararti C, Ceylan I. The Effect of Mulligan Mobilization Technique in Older Adults with Neck Pain: A Randomized Controlled, Double-Blind Study. Pain Res Manag. 2018 May 15;2018:2856375. doi: 10.1155/2018/2856375. eCollection 2018. — View Citation

He Y, Sun W, Zhao X, Ma M, Zheng Z, Xu L. Effects of core stability exercise for patients with neck pain: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2019 Nov;98(46):e17240. doi: 10.1097/MD.0000000000017240. — View Citation

Kim SY, An CM, Cha YS, Kim DH. Effects of sling-based manual therapy on cervicothoracic junction in patients with neck pain and forward head posture: A randomized clinical trial. J Bodyw Mov Ther. 2021 Jul;27:447-454. doi: 10.1016/j.jbmt.2021.03.007. Epub 2021 Mar 19. — View Citation

Kim YW, Kim NY, Chang WH, Lee SC. Comparison of the Therapeutic Effects of a Sling Exercise and a Traditional Stabilizing Exercise for Clinical Lumbar Spinal Instability. J Sport Rehabil. 2018 Jan 1;27(1):47-54. doi: 10.1123/jsr.2016-0083. Epub 2018 Jan 17. — View Citation

Lee J-D, Shin W-S. Immediate effects of neuromuscular control exercise on neck pain, range of motion, and proprioception in persons with neck pain. Physical Therapy Rehabilitation Science. 2020;9(1):1-9.

Lin KY, Tsai YJ, Hsu PY, Tsai CS, Kuo YL. Effects of Sling Exercise for Neck Pain: A Systematic Review and Meta-Analysis. Phys Ther. 2021 Aug 1;101(8):pzab120. doi: 10.1093/ptj/pzab120. — View Citation

Manzoor A, Anwar N, Khalid K, Haider R, Saghir M, Javed MA. Comparison of effectiveness of muscle energy technique with Mulligan mobilization in patients with non-specific neck pain. J Pak Med Assoc. 2021 Jun;71(6):1532-1524. doi: 10.47391/JPMA.981. — View Citation

Mun D-J, Oh H-J, Lee S-H. Effects of sling exercise on pain, trunk strength, and balance in patients with chronic low back pain. The Journal of Korean Physical Therapy. 2022;34(3):110-5.

Outcome

Type Measure Description Time frame Safety issue
Primary Numerical Pain Rating Scale Patient level of pain will be assessed using this scale. In a Numerical Rating Scale (NRS), this scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain" patients are asked to circle the number between 0 and 10, that fits best to their pain intensity.
NRS scores = 5 correspond to mild, scores of 6-7 to moderate and scores =8 to severe pain in terms of pain-related interference with functioning.
upto 4 weeks
Primary Neck Disability Index NDI is a simple ten-item questionnaire used to assess patients with neck pain. The questionnaire was devised and validated in English. It consists of ten questions each with six answers (scoring 0-5 points). The NDI has a fair to moderate test-retest reliability in patients with mechanical neck pain. upto 4 weeks
Primary Universal Goniometer A goniometer will be used in the study to measure shoulder flexion, internal rotation and external rotation.
Goniometer is an instrument that measures the available range of motion at a joint. To .measure the range of motion physical therapists most commonly use a goniometer. Therapist can use a goniometer to assess what the range of motion is at the initial assessment.
upto 4 weeks
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