NCT05542875

Brief Summary

Neck pain ranks as the 4th leading cause of disability, with high prevalence of mechanical neck pain in young population. As high as 30% of %. Individuals suffering from neck often report difficulty in performance of daily life, absence from work and decreased productivity. Several manual therapy treatment approaches are used for mechanical neck pain. The focus of this study is to compare the effectiveness of thrust and non-thrust thoracic manipulation for the treatment of mechanical neck pain in young population

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

September 13, 2022

Last Update Submit

September 13, 2022

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

  • Craniovertebral Angle

    Craniovertebral Angle wll be measured using Goniometer. CVA \>48 is considered normal, CVA \<48 is considered as Forward head posture. Immovable arm of the goniometer will be placed at the C7 spinous process and the movable arm at the tragus of the ear making an angle between the two lines, normal of which is 49.9 and angle less than that is considered as abnormal. Data will be collected directly from participants using Gomiometer before initiation of treatment and after 4th session.

    8 days

Secondary Outcomes (2)

  • Cervical Range of Motion

    8 days

  • Pain intensity

    8 days

Study Arms (2)

Group A (Thrust Manipulation)

EXPERIMENTAL

Participants will be randomly allocated to Group A which will recieve Thrust manipulation treatment in addition to standard treatment protocol. Prone thoracic extension manipulation technique will be applied from T2 - T6 to participants for 4 sessions on alternate days

Procedure: Thrust ManipulationProcedure: Standard Treatment

Group B (Non-Thrust Manipulation)

EXPERIMENTAL

Participants will be randomly allocated to group B which, in addition to standard treatment protocol, will recieve Maitland grade III or IV manipulation from T1 to T6. Posterior to anterior glide over spinous process will be maintained for 30 seconds. Participants will recieve 4 sessions on alternate days

Procedure: Non-Thrust manipulationProcedure: Standard Treatment

Interventions

Thrust ManipulationPROCEDURE

Prone thoracic extension manipulation technique will be applied from T2 - T6 to participants of Group A (Experimental group). Intervention will be applied on alternate days with a total of 4 treatment sessions

Group A (Thrust Manipulation)
Non-Thrust manipulationPROCEDURE

Maitland grade III or IV thoracic 0manipulation will be given to participants of Control group from T1 to T6. Posterior to anterior glide over spinous process will be maintained for 30 seconds. Intervention will be applied on alternate days with a total of 4 treatment sessions

Group B (Non-Thrust Manipulation)
Standard TreatmentPROCEDURE

Standard treatment protocol includes moist heat, TENS and Post isometric relaxation technique. Standard treatment will be given to both groups on every session. Standard treatment consists of: Superficial Moist Heat (Device): Superficial moist heat will me applied for 10 minutes on Upper Trapezius TENS (Device): TENS will be applied for 10 minutes at 80-100Hz, the electrodes will be placed at upper trapezius. Post-isometric Relaxation (procedure/surgery): 5-10 repetions of Post Isometric relaxation technique will be applied on various muscle groups which include Upper trapezius, levator scapulae, sternocleidomastoid and scalenes.

Group A (Thrust Manipulation)Group B (Non-Thrust Manipulation)

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders
  • Age: 18-24 years
  • Symptoms \<30 days
  • FABQPA score \<12
  • Increased upper thoracic spine kyphosis (visual estimate)
  • CVA \< 48 Degrees

You may not qualify if:

  • Symptoms distal to shoulder
  • Aggravation of symptoms with looking up
  • Radiating lower back pain
  • Neurological deficit
  • Previous surgery
  • Spondylolisthesis
  • Spinal stenosis
  • Inflammatory disease
  • Vertebrobasilar artery insufficiency
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

March 1, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

September 16, 2022

Record last verified: 2022-09

Locations

PA(1)