Effects of Cervical Spine Manipulation in Patients With Mechanical Neck Pain

NCT05649397 | Completed DMC

• 1 other identifier: REC- 01395 Hafsa Bint Bilal
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical neck pain is known as one of the most common disorders in musculoskeletal system. In elderly population, prevalence of neck pain ranges up to 38% while point prevalence and lifetime prevalence ranges from 6% to 22% and 14.2% to 71% respectively . Neck pain is defined by the international association for the study of pain as: "Pain perceived as arising from anywhere within the region bounded superiorly by superior nuchal line, inferior by transverse line through the tip of first thoracic spinous process, and laterally by sagittal plane tangential to the lateral border of neck" . There are variable causes of neck pain like trauma, infections, inflammatory conditions, musculoskeletal conditions, rheumatic diseases, and congenital diseases . There are varying degrees of disability and activity limitation caused by neck pain, like work productivity reduction and decrease quality of life . People who have a sedentary lifestyle, poor occupational postures, students with poor posture, people involved in occupation like computer programming, clerical job workers and desk job works are more likely to suffer from mechanical neck pain . Most common cause of mechanical neck pain is muscle tightness, Upper trapezius and levator scapulae are the most involved muscles

Conditions

Neck Pain

Keywords

pain; proprioception; blood pressure; respiratory rate; cervical manipulation

Outcome Measures

Primary Outcomes (5)

• Joint position sense test

  A target is placed on a wall 90cm away from the patient, at the patient's head height in sitting. The target is typically 40cm in diameter with concentric circles in 1cm increments. A laser pointer or similar targeting device is mounted onto a lightweight headband is then placed on the patient's head. The patient is then asked to focus on finding natural resting head position so that the laser pointer is in line with the center or "bullseye" of the target. With eyes closed, the patient will actively move their head in one plane of motion and attempt to return to the starting position as accurately as possible.

  four weeks

• Digital sphygmomanometer

  It is the most technologically advanced sphygmomanometer. It consists of an electronic sensor to measure the blood pressure and the readings are displayed on the digital monitor. To measure the blood pressure, the instrument measures the fluctuations of arteries

  four weeks

• Respiratory rate measurement

  To measure the respiratory rate of a person, ask the person to rest quietly for a moment. Start a timer for 60 seconds and count every time they breathe. Use the second hand on your watch or a timer on your phone to keep track of the person's breathing for exactly 1 minute. Once the minute starts, count every time you see their chest rise .

  four weeks

• NPRS (Numeric Pain Rating Scale).

  The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable while the NPRS exhibited moderate reliability

  four weeks

• NDI (U) (Neck Disability Index)

  The neck disability index is a ten-item self-reported questionnaire that assesses pain and associated disability, with a total max score of 50 points. An Urdu version of neck disability index will be used in this study. An intra-class correlation coefficient (ICC) revealed excellent test-retest reliability for all items (ICC = 0.86-0.98) and total scores (ICC = 0.99) of the NDI-U

  four weeks

Study Arms (2)

cervical manipulation

EXPERIMENTAL

in the cervical manipulation, provide a high velocity, low-amplitude manipulation to each subject's cervical spine.

Other: cervical manipulation

conventional therapy

ACTIVE COMPARATOR

* 15 mins moist hot pack * Neck Isometric exercise * hold for 5-8 seconds and repeat 10 times * Cervical range of motion * 10 repetitions of movement in rotation within pain free range

Other: conventional therapy

Interventions

cervical manipulation OTHER

provide a high velocity, low-amplitude manipulation to each subject's cervical spine.

cervical manipulation

conventional therapy OTHER

15 mins moist hot pack Neck Isometric exercise hold for 5-8 seconds and repeat 10 times Cervical range of motion 10 repetitions of movement in rotation within pain free range

conventional therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with non-radiating neck pain of moderate intensity scoring 4-8 on the numeric pain rating scale (NPRS)
• Have a Neck Disability Index (NDI) score of 20% or greater (10 points or greater on a 0-to-50 scale)
• Patients who have cervical joint position error greater than 7.1 cm or 4.5 degrees

You may not qualify if:

• Patients with a positive history of trauma, fracture or surgery of the cervical spine .
• anatomical cervical spine abnormality
• presented with any neurological signs
• history of benign paroxysmal positional vertigo
• Neck pain with radiation to the arm and upper extremity .
• Diagnosed cases of torticollis, and scoliosis
• History of osteoporosis, Any cardiac disorder
• had participated in a neck exercise program in the past 6 months .

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah international hospital Sihala

Islamabad, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Neck Pain; Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• maria Khalid, MSOMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: December 1, 2022
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)