Effectiveness of low-level electric current water bath on subjects with chronic non-specific neck pain
| ISRCTN | ISRCTN29695190 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29695190 |
| Secondary identifying numbers | HA-06-B-001 |
- Submission date
- 01/02/2020
- Registration date
- 05/02/2020
- Last edited
- 22/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
C/3/108, Guraiger
King Khalid University
Abha
61421
Saudi Arabia
| Phone | +966 (0)538901083 |
|---|---|
| jtedla@kku.edu.sa |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 11/02/2019 |
| Completion date | 11/05/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 34 |
| Total final enrolment | 34 |
| Key inclusion criteria | Chronic non-specific neck pain |
| Key exclusion criteria | 1. Malignancy 2. Neurological issues 3. Headaches with a specific diagnosis 4. Trauma 5. Infections 6. Skin cuts on upper limbs |
| Date of first enrolment | 25/02/2019 |
| Date of final enrolment | 31/10/2019 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Gate 5, Building C
Guraiger
Abha
61421
Saudi Arabia
Sponsor information
University/education
C/3/108, Guraiger
King Khalid University
Abha
61421
Saudi Arabia
| Phone | +966 17 2419516 |
|---|---|
| dsr@kku.edu.sa | |
| Website | http://www.kku.edu.sa/ |
"ROR" |
https://ror.org/052kwzs30 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- جامعة الملك خالد, KKU
- Location
- Saudi Arabia
Results and Publications
| Intention to publish date | 01/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Upon the completion of the study, it will be published in the peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/10/2020 | 22/10/2020 | Yes | No |
Editorial Notes
05/02/2020: Trial’s existence confirmed by King Khalid University
