Condition category
Musculoskeletal Diseases
Date applied
01/02/2020
Date assigned
05/02/2020
Last edited
05/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Neck pain is one of the world's leading causes for the years lived with disability. Ambiguity in the effect of electrotherapy modalities for the treatment of Chronic Non-Specific Neck Pains (CNSNP) needs to be studied further.
A number of treatments are widely prescribed for chronic pain syndromes and are not fully effective. In clinical practice, the effectiveness of electrotherapy is limited in particular to hydro galvanic bath therapy in the management of chronic pain syndromes, which needs to be evaluated.
Aim: This study aims to evaluate whether hydro galvanic therapy can be beneficial in decreasing pain, pain pressure threshold and increasing quality of life in subjects with chronic nonspecific neck pain.

Who can participate?
Patients aged 18 years or above with chronic non-specific neck pain.

What does the study involve?
Subjects will be divided at random into to study group and the control group. The subjects in the study group will receive a hydro-galvanic bath along with exercises and control group subjects will receive Trans-cutaneous Electrical Nerve Stimulation (TENS) along with exercises for 4 sessions per week for 12 weeks.

What are the possible benefits and risks of participating?
The subjects will be getting 12 weeks of hydrogalvanic bath treatment without any cost. Along with this, they will be getting free consultation, assessment and exercise programs from experienced therapists. There is no risk involved due to our treatment it is absolutely safe for them.

Where is the study run from?
King Khalid University (Saudi Arabia)

When is the study starting and how long is it expected to run for?
February 2019 to May 2020

Who is funding the study?
King Khalid University (Saudi Arabia)

Who is the main contact?
Dr Jaya Shanker Tedla
jtedla@kku.edu.sa

Trial website

Contact information

Type

Public

Primary contact

Dr Jaya Shanker Tedla

ORCID ID

Contact details

C/3/108
Guraiger
King Khalid University
Abha
61421
Saudi Arabia
+966 (0)538901083
jtedla@kku.edu.sa

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

HA-06-B-001

Study information

Scientific title

Effectiveness of hydro galvanic bath on improving pain, disability and quality of life in subjects with chronic non-specific neck pain: a randomized control trial

Acronym

Study hypothesis

The hydro galvanic bath will be effective in improving pain, disability and quality of life in subjects with chronic non-specific neck pain

Ethics approval

Approved 11/02/2019, The scientific research ethics committee of King Khalid University (Deanship of Scientific Research, 3rd floor, Building D, King Khalid University, Guraiger, Abha - 61481, Kingdom of Saudi Arabia; +966 17 2418336; ecm@kku.edu.sa), ref: HA-06-B-001

Study design

Interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Chronic non-specific neck pain

Intervention

The subjects will be divided into to study group and the control group by block randomization.

The subjects in the study group will receive a hydro-galvanic bath along with exercises.
Control group subjects will receive Trans-cutaneous Electrical Nerve Stimulation (TENS) along with exercises for 4 sessions per week for 12 weeks.

Outcome measures: Pain by Visual Analog Scale (VAS), Disability by Neck Disability Index, and Quality of Life by Short form 36 (SF-36) will be evaluated pre and post 12 weeks intervention.

Intervention type

Device

Phase

Not Applicable

Drug names

Hydro galvanic bath

Primary outcome measure

Pre and post 12 weeks intervention:
1. Pain with Visual Analog Scale (VAS)
2. Disability with Neck Disability Index (NDI)
3. Quality of life with Short Form-36 (SF-36)

Secondary outcome measures

Age at disease onset

Overall trial start date

11/02/2019

Overall trial end date

11/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Chronic non-specific neck pain

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

34

Participant exclusion criteria

1. Malignancy
2. Neurological issues
3. Headaches with a specific diagnosis
4. Trauma
5. Infections
6. Skin cuts on upper limbs

Recruitment start date

25/02/2019

Recruitment end date

31/10/2019

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

King Khalid University
Physical Therapy Out-Patient Clinic Gate 5, Building C Guraiger
Abha
61421
Saudi Arabia

Sponsor information

Organisation

King Khalid University

Sponsor details

C/3/108
Guraiger
King Khalid University
Abha
61421
Saudi Arabia
+966 17 2419516
dsr@kku.edu.sa

Sponsor type

University/education

Website

http://www.kku.edu.sa/

Funders

Funder type

University/education

Funder name

King Khalid University

Alternative name(s)

KKU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Saudi Arabia

Results and Publications

Publication and dissemination plan

Upon the completion of the study, it will be published in the peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

01/07/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/02/2020: Trial’s existence confirmed by King Khalid University