NCT06437483

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 27, 2024

Last Update Submit

May 27, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Group A

EXPERIMENTAL

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.

Procedure: Sustained Natural Apophyseal GlidesProcedure: KinesiotapingProcedure: Conventional Treatment

Group B

ACTIVE COMPARATOR

Participants in group B will receive Sustained Natural Apophyseal Glides along with the conventional treatment.

Procedure: Sustained Natural Apophyseal GlidesProcedure: Conventional Treatment

Interventions

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.

Group AGroup B
KinesiotapingPROCEDURE

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.

Group A

Hot pack (moist heat) and TENS will be applied, each for 10 minutes.

Group AGroup B

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 460000, Pakistan

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Fatima Riaz, MS-MSKPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In this study, participants are blinded to their assigned treatment groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2024

First Posted

May 31, 2024

Study Start

November 10, 2023

Primary Completion

May 30, 2024

Study Completion

June 30, 2024

Last Updated

May 31, 2024

Record last verified: 2024-05

Locations