NCT05074615

Brief Summary

To determine the effects of cranio-cervical flexion training on the cervical proprioception and pain in patients with mechanical neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2022

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

September 29, 2021

Last Update Submit

March 8, 2022

Conditions

Keywords

Mechanical neck painProprioceptive trainingDeep cervical flexors

Outcome Measures

Primary Outcomes (1)

  • Cervical Range of Motion

    The unit of CROM has three inclinometers attached to it and each inclinometer collects degree of movement in each plane.. One the CROM device is mounted on the patient's head, instructions are given to the patient regarding their neutral head movements and target head movements which are Right and Left sided rotation, Right and Left sided lateral flexion and cervical flexion and extension. After that, patient is blindfolded and all the movements are performed with patient being blindfolded. No feedback should be given during the ongoing session. This entire procedure takes around 15 minutes for one individual.

    3 weeks

Secondary Outcomes (1)

  • Numeric Pain Rating Scale

    3 weeks

Study Arms (2)

Cranio-Cervical Flexion Training Group

EXPERIMENTAL

Participants of this group will receive conventional training along with cranio-cervical flexion training and home plan. Cranio-cervical flexion training will be given with the help of pressure biofeedback unit. the cuff will be inflated at a specific pressure level and patient will be asked to maintain that pressure and gradually increase it.

Other: Cranio-Cervical Flexion TrainingOther: Conventional Therapy

Conventional Therapy Group

ACTIVE COMPARATOR

Participants of this group will receive only conventional therapy and home plan will be given which includes; hot pack, TENS, neck isometrics and passive stretching of neck musculature. Home plan will include self-stretches and neck isometrics.

Other: Conventional Therapy

Interventions

Participants of this group will receive conventional training along with Cranio-cervical flexion training: * The pressure cuff is placed behind the neck just next to the occiput and inflated up to a baseline pressure of 20 mmHg. The patient is asked to perform Cranio-Cervical Flexion (CCF) to sequentially reach 5 pressure targets in 2 mmHg increments from a baseline of 20 mmHg to the final level of 30 mmHg. For each target level, the patient is instructed to maintain the contraction for 10 sec for 10 repetitions with brief rest periods between each contraction i.e., 3-5 seconds. Once a set of 10 repetitions of 10 sec is achieved at one target level, the exercise is progressed to train at the next target level up to the final target level at 30 mmHg. Conventional therapy will be given along with home plan. Exercise protocol will consist of 30 minutes. Exercise will have total 3 sessions/week for 3 weeks.

Cranio-Cervical Flexion Training Group

Participants of this group will receive only conventional therapy and home plan will be given which includes; * Hot pack placed on the posterior neck for 15 minutes. * Transcutaneous electrical nerve stimulation (TENS) with a frequency of 80 Hz for 20 minutes with 10-30 mA intensity. * Isometric exercises: Isometric neck flexion, extension, side bending exercises. 10 repetitions. Hold period is 10 seconds for each movement. Resistance would be provided manually by the therapist. * Stretching exercises: Passive stretching for Sternocleidomastoid, Trapezius, Pectoralis Major. 10 reps and each stretch maintained for 10 seconds. * Home Plan: Patients will be given a home plan of self-stretches and isometrics and instructions on how to perform and number of repetitions will be guided. Exercise protocol will consist of 25 minutes. Exercise will consist of total 3 sessions/week for 3 weeks

Conventional Therapy GroupCranio-Cervical Flexion Training Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with mechanical neck pain with minimum duration of 4 weeks,
  • Pain in the cervical region with moving or palpating the cervical spine,
  • upper cervical involvement with or without headache and C1-C2 rotational deficits.

You may not qualify if:

  • Vertebrobasilar insufficiency.
  • Any history of serious underlying pathology, cervical trauma, structural deformities, genetic spinal disorders or previous spinal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPIRE Medical Mall

Islamabad, Punjab Province, 45720, Pakistan

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Saad Rauf, Master

    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

September 29, 2021

First Posted

October 12, 2021

Study Start

November 2, 2021

Primary Completion

February 17, 2022

Study Completion

February 17, 2022

Last Updated

March 23, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations