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
Funders
Funder type
University/education
Funder name
King Khalid University
Alternative name(s)
جامعة الملك خالد, KKU
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
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