Effects of Dynamic taping on pain, disability, mobility and endurance among subjects with low back pain
| ISRCTN | ISRCTN12043220 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12043220 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | ECM#2019-71 |
| Sponsor | King Khalid University |
| Funder | King Khalid University |
- Submission date
- 05/12/2019
- Registration date
- 14/12/2019
- Last edited
- 17/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Low back pain (LBP) is a significant public health condition and is associated with a high rate of absenteeism from work, disability, and frequent use of health services. Current literature provides several possibilities for the treatment of LBP that vary according to the duration of symptoms and classification of this condition. These treatments range from educational programs to behavioral cognitive therapy, medication, electrophysical agents, manual therapy, general exercises, and specific spinal stabilization exercises, among others. Although the aforementioned treatments have been extensively adopted, they exert a moderate effect at most, with recurrences typically noted. Therefore, patients and clinicians critically require more effective therapeutic approaches. Several types of tape and their associated application methods are available, with different underlying philosophies regarding their modes of action. Kinesio tape, Dynamic tape, Rigid tape, Micropore tape, Athletic tape, and many other types are available to manage and/or rehabilitate the injuries. Dynamic taping (DT) is a relatively new treatment technique, which is increasingly becoming an adjuvant method to treat musculoskeletal problems. In the year 2009, Kendrick produced DT which is made up of visco-elastic nylon and lycra blend material which has the ability to stretch in four directions, strong elastic resistance and recoil, a high degree of stretch (more than 200%) with no rigid endpoint and visco-elastic properties. The primary mode of action of DT is mechanical (deceleration of eccentric action, load absorption, and assistance of movement) and the second mode of action is neurophysiological. However, no research has evaluated the effects of DT on LBP and the aim of the present study is to determine the effect of DT in the treatment of chronic non-specific low back pain (chronic NSLBP).
Who can participate?
Adults over the age of 18 and who attend the out-patient physiotherapy clinics of King Khalid University Hospital, Abha, Saudi Arabia
What does the study involve?
Participants are requested to join this study while they are at an out-patient physiotherapy clinic. Initial examination/assessment is done for inclusion in the study. A small piece of Dynamic tape (DT) and Kinesiology tape (KT) is applied to the right and left forearms, respectively. The next day (after 24 hours), the researcher examines the forearm and makes sure that there is no allergic reaction. If any allergic reactions present then the participant is excluded from the study. The pre-test assessment is carried out and the participants are randomly allocated to one of three groups. Dynamic tape is applied parallel to the spine from the posterior superior iliac spine (PSIS) to T12 thoracic vertebra for the first group (Experimental Group 1). For those in the second group (Experimental Group 2), the Kinesiology tape is applied from the posterior superior iliac spine (PSIS) to T12 thoracic vertebra. No treatment is received by the control group. After the application of the tapes, the patients undergo the same pre-test measurements after 2 hours of tape application. The participants are instructed to re-visit after 3 days and the measurements are taken in the presence of tape. After completing the measurements, the routine treatment is given to all the participants (experimental group 1, experimental group 2, and control group).
What are the possible benefits and risks of participating?
The application of tape can be considered as an adjuvant for the main treatment for chronic non-specific low back pain. The tape may minimize/prevent wrong postural movements. There is no risk of participating in this study except allergic reactions to tape application.
Where is the study run from?
The study is being run by the King Khalid University, Abha, Saudi Arabia and takes place in out-patient physiotherapy clinics of King Khalid University.
When is the study starting and how long is it expected to run for?
December 2019 to February 2020
Who is funding the study?
King Khalid University (Saudi Arabia)
Who is the main contact?
1. Mr Kanagaraj Rengaramanujam
krenga@kku.edu.sa
2. Dr Ravi Shankar Reddy
rshankar@kku.edu.sa
Contact information
Scientific
Post Box No: 3665
Department of Medical Rehabilitation Sciences
College Of Applied Medical Sciences
King Khalid University
Guraigar
Abha
61481
Saudi Arabia
| 0000-0002-0244-7645 | |
| Phone | +966 (0)530784265 |
| krenga@kku.edu.sa |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Immediate and short-term effects of Dynamic taping on pain, disability, mobility and endurance among subjects with chronic non-specific low back pain – a randomized controlled trial |
| Study acronym | DTCNSLBP (Dynamic Tape on Chronic Non-Specific Low Back Pain) |
| Study objectives | 1. Application of Dynamic tape is more immediately effective than Kinesiology tape in decreasing pain, improving disability and range of motion and enhance back endurance capacity among subjects with chronic non-specific low back pain. 2. Application of Dynamic tape is more effective in the short term (3 days) than Kinesiology tape in decreasing pain, improving disability and range of motion and enhance back endurance capacity among subjects with chronic non-specific low back pain. |
| Ethics approval(s) | Approved 30/10/2019, Research Ethics Committee of King Khalid University, Abha, Kingdom of Saudi Arabia (Chair of Ethical Committee of the Scientific Research, Deanship of Scientific Research, King Khalid University, Abha, Asir Region, Kingdom of Saudi Arabia; Tel: +966 (0)17 2418667; Email: ecm@kku.edu.sa), ref: ECM#2019-71 (HAPO-06-B-001) |
| Health condition(s) or problem(s) studied | Chronic non-specific low back pain |
| Intervention | The participants are allocated to the groups (three groups) using block randomization with concealed envelopes and the random table derived from the website randomization.com. Group 1: Experimental 1 (Dynamic tape application) Group 2: Experimental 2 (Kinesiology tape application) Group 3: Control (No tape application) The Dynamic tape is applied parallel to the spine both right and left from the posterior superior iliac spine (PSIS) to T12 (thoracic) vertebrae for the experimental group (Group 1). The Kinesiology tape is applied parallel to the spine both right and left from the posterior superior iliac spine (PSIS) to T12 (thoracic) vertebrae for the experimental group (Group 2). No treatment is received by the control group. Once the participants allocated into groups, a small piece of tape (Dynamic or Kinesiology tape) applied on the forearm of participants. Next day (after 24 hours) the researcher will evaluate the allergic reaction to taping. Once the researcher confirms there is no allergic reaction, then the pre-test assessment will be done. After completing the pre-test assessment, the interventional tapes are applied to the participants according to the experimental groups (Group 1 or Group 2). The post-test assessment 1 will be done immediately after the application of the interventional tapes. The time interval (duration) between the pre-test assessment and the post-test assessment 1 will be 2 hours. The post-test assessment 2 will be done on the 3rd day in the presence of tape on the subject’s body. The total duration of the study for each participant is 5 days. After completing the study, routine treatment will be given to all the participants of the study (subjects in the experimental and control group). |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Pain intensity is recorded by the participant using a 10-cm visual analogue scale (VAS), where 0 represented no pain and 10 represented unbearable pain. Pain assessed before application of Dynamic tape or Kinesiology tape (Pre-test); it will be assessed immediately after the application of tapes (Post-test 1) and the pain assessed again after the 3rd day of tape application (Post-test 2). |
| Key secondary outcome measure(s) |
1. Mobility: Spinal mobility assessed by two methods: |
| Completion date | 10/02/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 45 |
| Total final enrolment | 45 |
| Key inclusion criteria | 1. Patients with LBP of at least 30 days in duration and aged between 18 and 60 years 2. Pain intensity with minimum scoring of 3 on a Visual Analog Scale (VAS) 3. Disability with minimum scoring of 20 out of 100 in Oswestry Disability Index (ODI) |
| Key exclusion criteria | 1. Patients with any contraindications to the use of taping (skin diseases) 2. Pain radiating to the knee 3. Known or suspected serious congenital or acquired spinal pathology, spinal surgery history, lumbar disc herniation, spinal deformity, rheumatoid arthritis or spondyloarthropathy diagnosis 4. Unable to tolerate the Biering-Sorensen test |
| Date of first enrolment | 15/12/2019 |
| Date of final enrolment | 31/01/2020 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
College Of Applied Medical Sciences
Abha
61481
Saudi Arabia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available if required by the journal. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 29/09/2020 | 17/01/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/01/2023: Publication reference and total final enrolment added.
09/12/2019: Trial's existence confirmed by Research Ethics Committee of King Khalid University.