NCT04617288

Brief Summary

Neck pain is second largest cause of disability worldwide. Chronic neck pain prevalence is 14% which is somewhat higher in females as compared to males. In India reported prevalence is 6%. Therapeutically, neck pain is managed by physiotherapists using rest, stretching and strengthening exercises, educating patient, and intense proprioception and positional exercises.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 10, 2015

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2015

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

15 days

First QC Date

October 30, 2020

Last Update Submit

November 5, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Visual analog scale

    Visual analog scale is a subjective outcome measurement where patients judge the intensity of their pain on a scale of 0-10, which is in the form of a 10cm straight line. On this 0-10 scale, zero denotes no pain and ten denotes severe pain intensity.

    2 weeks

  • Neck Range of motion

    Range of motion of the cervical spine measured by bubble inclinometer. It consists of a 360-degree scale with a fluid filled circular tube containing a small air bubble. It is a gravity dependent Goniometer, which uses the gravity's effect on fluid level to measure joint position and motion.

    2 weeks

Secondary Outcomes (1)

  • Neck disability Index

    2 weeks

Study Arms (2)

Mean and standard deviations of age and height between group A and B

EXPERIMENTAL

100 subjects with a mean age of 30.82±6.75 (group A, 31.42±6.67; group B, 30.82±6.82) ranging from 20 to 45 years, with a mean height of 165.52±7.85 (group A, 164.92±7.79; group B, 166.12±7.87) centimeters

Other: Ultrasound Therapy, SNAGs

Between group comparison of VAS, NDI and ROM

EXPERIMENTAL

VAS, NDI and Neck ROM between two groups were compared at pretest (0 day) and posttest (end of two weeks)

Other: Ultrasound Therapy, SNAGs

Interventions

Also known as: Hot Pack, Exercise
Between group comparison of VAS, NDI and ROMMean and standard deviations of age and height between group A and B

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age group between 20- 45 years.
  • Both Gender male and female.
  • Individuals having localized pain or stiffness in spine or both combined b/w C3 to C7 without upper limbs radiculopathy.
  • Pain reported on VAS score ˃3 in neck region.
  • Patients agree to sign written consent form.

You may not qualify if:

  • T.B, carcinoma, heart disease, osteoporosis.
  • Neural disorders due to PIVD.
  • Any trauma or localized infection in neck region.
  • Upper MND, cervical stenosis, metabolic diseases in bone and joint.
  • Hyper flexibility
  • Open sores,
  • Ongoing radiotherapy, chemotherapy, steroid therapy or anticoagulants.
  • Psychiatric diseases such as phobia/obsession, depression.
  • Allergy to hot pack
  • Patients with history of surgery in cervical spine region with in a year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Interventions

Ultrasonic TherapyExercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants randomly assigned to group A receiving conventional Physiotherapy plus SNAGs and group B receiving conventional Physiotherapy plus ultrasound.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 5, 2020

Study Start

August 10, 2015

Primary Completion

August 25, 2015

Study Completion

August 25, 2015

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share