NCT04941495

Brief Summary

It is a randomized control trial will be conducted at Federal Government Polyclinic hospital on 44 chronic mechanical neck pain patients. Patients will be recruited in the study through non probability purposive sampling. Random allocation will be done through toss coin method into two groups; Conventional Physiotherapy Control group (n=22) and Proprioceptive training Experimental group (n=22). Research data will be collected through structural questionnaires. Tools will be used to collect data are NPRS, NDI, Goniometer (Cervical ROMs) and proprioception.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

20 days

First QC Date

June 22, 2021

Last Update Submit

September 2, 2021

Conditions

Keywords

chronin non traumatic neck painJoint position errorCervical ProprioceptionNDI

Outcome Measures

Primary Outcomes (4)

  • Numeric Pain Rating Scale (NPRS)

    The Numeric Pain Rating Scale (NPRS) is a one-dimensional measure of pain intensity in patients. The NPRS is a numeric version of the visual analog scale (VAS) in which patient selects a number (0-10) from a horizontal line that best depict the intensity of their pain. 0 represents no pain and 10 represents pain as bad as one can imagine.

    2 weeks

  • Neck Disability Index

    NDI is the most widely used instrument for assessing self rated disability in patients with neck pain. It has a total of 10 sections of the following domain: Pain intensity, personal care, carrying weights, reading, headaches, concentration, work, driving, sleep disturbances and recreational activities. Each of the 10 items is scored from 0 (No disability) to 5 (Complete disability).

    2 weeks

  • Range of Motion

    Range of motion is a movement potential of a joint in which it moves in its possible availble range. For cervical spine active movements of the neck were recorded in sitting postion. Universal goniometer was used to measure patient's active flexion, extension, Left and right side bendings, left and right side rotations.

    2 weeks

  • Cervical Proprioception

    The treatment protocol used for the patients in experimental group was also used as an outcome measurement tool in this study. Patient's cervical proprioception was measured through a procedure adapted by Clark's Joint position error testing. Patients proprioception was assessed on day one and on the last day of their treatment.

    2 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

It Includes the TENS, Infrared, Isometric and stretching exercises along with the home plan and postural education

Other: conventional physiotherapy

Experimental Group

EXPERIMENTAL

It Includes the TENS, Infrared, Isometric and stretching exercises along with the home plan and postural education. It also include the cervical proprioceptive training

Other: Cervical proprioceptive training

Interventions

1. TENS for 15 minutes on Constant Mode according to patient comfort. 2. Infrared for 15 minutes. 3. Isometric exercises: Isometric neck flexion, extension, side bending exercises were given. 3 sets of 10 repetitions each were given. And resistance was given for 6-8 seconds for each movement. 4. Stretching exercises: Passive stretching for Sternocleidomastoid, short sub occipital muscles, Trapezius \& Scalene, Pectoralis Major was given. 3 sets of 10 reps were given and each stretch was maintained for 10 seconds. 5. Home Plan: self stretches and isometrics. 6. Postural Education: posture correction in daily life activities in sitting, walking, lying.

Control Group

1. TENS for 15 minutes on Constant Mode according to patient comfort. 2. Infrared for 15 minutes. 3. Isometric exercises: Isometric neck flexion, extension, side bending exercises were given. 3 sets of 10 repetitions each were given. And resistance was given for 6-8 seconds for each movement. 4. Stretching exercises: Passive stretching for Sternocleidomastoid, short sub occipital muscles, Trapezius \& Scalene, Pectoralis Major was given. 3 sets of 10 reps were given and each stretch was maintained for 10 seconds. 5. Home Plan: self stretches and isometrics. 6. Postural Education: posture correction in daily life activities in sitting, walking, lying. 7. The patients wearing a cap with a laser pointer attached to it were seated three feet away from the target A, B and C. Start Chart A with a 3 cm, chart B 2cm and chart C 1cm narrow pathway were presented to the patients. The time taken by the patient to complete the pathway without any error was noted.

Experimental Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mechanical neck pain of Chronic duration (Symptoms present form more than 3 months)
  • Limitation of cervical ROM
  • Age 18-55
  • Men and Women

You may not qualify if:

  • Sharp purser test positive
  • Vertebral artery insufficiency test positive Neck pain due to:
  • Inflammatory conditions - infections, ankylosing spondylitis, juvenile arthritis, rheumatoid arthritis and polymyalgia rheumatica.
  • Metabolic - osteoporosis, osteomalacia, Paget's disease, gout.
  • Neoplastic - metastases, myeloma, intrathecal tumours.
  • Referred pain as a result of - angina pectoris, aortic aneurysm, pancoast tumour, diaphragmatic pathology, pharyngial pathology
  • Neck injury due to trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal Government Polyclinic Hospital, Islamabad.

Islamabad, Capital, 44000, Pakistan

Location

Related Publications (14)

  • Vernon H, Humphreys K, Hagino C. Chronic mechanical neck pain in adults treated by manual therapy: a systematic review of change scores in randomized clinical trials. J Manipulative Physiol Ther. 2007 Mar-Apr;30(3):215-27. doi: 10.1016/j.jmpt.2007.01.014.

    PMID: 17416276BACKGROUND
  • Falla D. Unravelling the complexity of muscle impairment in chronic neck pain. Man Ther. 2004 Aug;9(3):125-33. doi: 10.1016/j.math.2004.05.003.

    PMID: 15245706BACKGROUND
  • May S, Gardiner E, Young S, Klaber-Moffett J. Predictor Variables for a Positive Long-Term Functional Outcome in Patients with Acute and Chronic Neck and Back Pain Treated with a McKenzie Approach: A Secondary Analysis. J Man Manip Ther. 2008;16(3):155-60. doi: 10.1179/jmt.2008.16.3.155.

    PMID: 19119405BACKGROUND
  • Royuela A, Kovacs FM, Campillo C, Casamitjana M, Muriel A, Abraira V. Predicting outcomes of neuroreflexotherapy in patients with subacute or chronic neck or low back pain. Spine J. 2014 Aug 1;14(8):1588-600. doi: 10.1016/j.spinee.2013.09.039. Epub 2013 Oct 18.

    PMID: 24345468BACKGROUND
  • Peterson C, Bolton J, Humphreys BK. Predictors of outcome in neck pain patients undergoing chiropractic care: comparison of acute and chronic patients. Chiropr Man Therap. 2012 Aug 24;20(1):27. doi: 10.1186/2045-709X-20-27.

    PMID: 22920497BACKGROUND
  • Fernandez-de-las-Penas C, Palomeque-del-Cerro L, Rodriguez-Blanco C, Gomez-Conesa A, Miangolarra-Page JC. Changes in neck pain and active range of motion after a single thoracic spine manipulation in subjects presenting with mechanical neck pain: a case series. J Manipulative Physiol Ther. 2007 May;30(4):312-20. doi: 10.1016/j.jmpt.2007.03.007.

    PMID: 17509440BACKGROUND
  • Kanlayanaphotporn R, Chiradejnant A, Vachalathiti R. The immediate effects of mobilization technique on pain and range of motion in patients presenting with unilateral neck pain: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Feb;90(2):187-92. doi: 10.1016/j.apmr.2008.07.017.

    PMID: 19236972BACKGROUND
  • Kristjansson E, Treleaven J. Sensorimotor function and dizziness in neck pain: implications for assessment and management. J Orthop Sports Phys Ther. 2009 May;39(5):364-77. doi: 10.2519/jospt.2009.2834.

    PMID: 19411769BACKGROUND
  • Kristjansson E, Leivseth G, Brinckmann P, Frobin W. Increased sagittal plane segmental motion in the lower cervical spine in women with chronic whiplash-associated disorders, grades I-II: a case-control study using a new measurement protocol. Spine (Phila Pa 1976). 2003 Oct 1;28(19):2215-21. doi: 10.1097/01.BRS.0000089525.59684.49.

    PMID: 14520034BACKGROUND
  • Rolli Salathe C, Elfering A. A Health- and Resource-Oriented Perspective on NSLBP. ISRN Pain. 2013 Sep 11;2013:640690. doi: 10.1155/2013/640690. eCollection 2013.

    PMID: 27335880BACKGROUND
  • Hush JM, Michaleff Z, Maher CG, Refshauge K. Individual, physical and psychological risk factors for neck pain in Australian office workers: a 1-year longitudinal study. Eur Spine J. 2009 Oct;18(10):1532-40. doi: 10.1007/s00586-009-1011-z. Epub 2009 Apr 28.

    PMID: 19399537BACKGROUND
  • Descarreaux M, Mayrand N, Raymond J. Neuromuscular control of the head in an isometric force reproduction task: comparison of whiplash subjects and healthy controls. Spine J. 2007 Nov-Dec;7(6):647-53. doi: 10.1016/j.spinee.2006.10.001. Epub 2006 Dec 22.

    PMID: 17509939BACKGROUND
  • Clark NC, Roijezon U, Treleaven J. Proprioception in musculoskeletal rehabilitation. Part 2: Clinical assessment and intervention. Man Ther. 2015 Jun;20(3):378-87. doi: 10.1016/j.math.2015.01.009. Epub 2015 Jan 29.

    PMID: 25787919BACKGROUND
  • Newcomer KL, Laskowski ER, Yu B, Johnson JC, An KN. Differences in repositioning error among patients with low back pain compared with control subjects. Spine (Phila Pa 1976). 2000 Oct 1;25(19):2488-93. doi: 10.1097/00007632-200010010-00011.

    PMID: 11013501BACKGROUND

Study Officials

  • Iqra Raja, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Random allocation will be done through toss coin method into two groups; Conventional Physiotherapy Control group (n=22) and Proprioceptive training Experimental group (n=22).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 28, 2021

Study Start

June 22, 2021

Primary Completion

July 12, 2021

Study Completion

July 15, 2021

Last Updated

September 10, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations