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Effects of Thrust Versus Non-Thrust Thoracic Manipulation on Mechanical Neck Pain.

Primary Purpose

Neck Pain

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Thrust Manipulation
Non-Thrust manipulation
Standard Treatment
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

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

Exclusion Criteria

  • 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

Sites / Locations

  • Foundation University College of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A (Thrust Manipulation)

Group B (Non-Thrust Manipulation)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cervical Range of Motion
Cervical Range of motion will be measured using bubble inclinometer. Measurement will be taken before the initiation of treatment and after 4Th treatment session. Increase in Cervical ROM will be considered a positive outcome.
Pain intensity
Pain will be assessed using Numeric pain rating scale which comprises of 11 points where point (0) signifies no pain and point (10) signifies worst imaginable pain. Measurement will be taken before the initiation of treatment and after 4Th treatment session. Low score for the NPRS will be considered a positive outcome.

Full Information

First Posted
September 13, 2022
Last Updated
September 13, 2022
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT05542875
Brief Title
Effects of Thrust Versus Non-Thrust Thoracic Manipulation on Mechanical Neck Pain.
Official Title
Effects of Thrust Versus Non-Thrust Thoracic Manipulation on Mechanical Neck Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
craniovertebral angle, cervical range of motion and pain will be noted for each participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Thrust Manipulation)
Arm Type
Experimental
Arm Description
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
Arm Title
Group B (Non-Thrust Manipulation)
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Thrust Manipulation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Non-Thrust manipulation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Standard Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Craniovertebral Angle
Description
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.
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Cervical Range of Motion
Description
Cervical Range of motion will be measured using bubble inclinometer. Measurement will be taken before the initiation of treatment and after 4Th treatment session. Increase in Cervical ROM will be considered a positive outcome.
Time Frame
8 days
Title
Pain intensity
Description
Pain will be assessed using Numeric pain rating scale which comprises of 11 points where point (0) signifies no pain and point (10) signifies worst imaginable pain. Measurement will be taken before the initiation of treatment and after 4Th treatment session. Low score for the NPRS will be considered a positive outcome.
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Both genders Age: 18-24 years Symptoms <30 days FABQPA score <12 Increased upper thoracic spine kyphosis (visual estimate) CVA < 48 Degrees Exclusion Criteria 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
Facility Information:
Facility Name
Foundation University College of Physical Therapy
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

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Effects of Thrust Versus Non-Thrust Thoracic Manipulation on Mechanical Neck Pain.

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