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Ankle SprainsICE-BOWNCT06675006

Comparing Bowen Therapy With Ice to Medical Massage for Acute Ankle Sprain

An observational study of Ankle Sprains, run by Rehabilitation Centre Zivot at 1 site in Bosnia and Herzegovina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Foot pain is particularly prevalent among older adults, affecting approximately 20% to 37% of men and women aged 45 years and older living in the community. Ankle pain is somewhat less common. Read more about this study

Who is it for?
Any age
Conditions the study is for
Ankle Sprains
What is being tested?
Medical Massage
How many people
40 participants
Where
1 siteBosnia and Herzegovina
Study dates
1 Jun 2024to 1 Oct 2024
How long will I take part?
15 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study population consists of 40 adult participants aged between 32 and 75 years, with a mean age of 52.1 years (SD ± 10.6). Participants are randomly assigned to two groups: one receiving Bowen therapy and the other receiving medical massage, allowing for a comparative analysis of the efficacy of each intervention. All participants provided informed consent prior to enrollment in the study and are expected to attend all scheduled therapy sessions and follow-up assessments.

Who may be able to join

  • Participants aged 32 to 75 years.
  • Diagnosed with ankle sprain by a qualified healthcare professional (physiatrist or orthopedist).
  • Able to provide informed consent.
  • Willing to comply with the study protocol and attend all scheduled therapy sessions.

Who cannot join

  • Presence of serious spinal pathologies (e.g., cancer, osteoporosis, trauma, or fracture).
  • History of significant neurological disorders or conditions affecting mobility.
  • Pregnancy or breastfeeding.
  • Previous surgical interventions on the spine or significant other surgeries within the last six months.
  • Current use of medications that affect pain perception (e.g., opioids).
  • Participation in other therapeutic interventions for low back pain during the study period.

Trial locations and contacts

1 site in 1 country.

Bosnia and Herzegovina1 site

  • Rehabilitation Centre Život

    Mostar, 88000

Other trials in Bosnia and Herzegovina

About this study

Official title: Comparative Analysis of Cryotherapy Combined With Bowen Therapy Versus Medical Massage for Managing Acute Ankle Sprain

Foot pain is particularly prevalent among older adults, affecting approximately 20% to 37% of men and women aged 45 years and older living in the community. Ankle pain is somewhat less common. This study evaluates the combined impact of cryotherapy (ice application) with Bowen therapy versus traditional medical massage in alleviating symptoms. A total of 41 patients, aged 32-75 years participated and were divided into two treatment groups: one receiving medical massage and ice, and the other Bowen therapy and ice, with three sessions over 15 days. Pain and functionality were measured using the VAS pain scale and Roland-Morris questionnaire. Findings revealed improvements in both groups, with the Bowen therapy group achieving greater pain reduction and functional improvement, suggesting potential advantages of Bowen therapy combined with cryotherapy for managing symptoms.

Conditions
Ankle Sprains
Being tested
Medical Massage
Keywords
Bowen therapy, Cryotherapy
Medical subject headings
Ankle Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical MassageCombination product

    Also called Bowen therapy, Cryotherapy

    This intervention refers to the application of therapeutic massage techniques aimed at alleviating pain and enhancing muscle relaxation in patients with nonspecific low back pain. The treatment focuses on manipulating soft tissues, including muscles, tendons, and fascia, to improve circulation, reduce muscle tension, and promote overall wellness. Medical massage is tailored to each patient's specific needs and can incorporate various techniques, including Swedish massage, Bowen Therapy, a gentle and non-invasive manual therapy, utilizes precise movements on specific points of the body to promote healing and restore balance. The therapist applies light pressure with the fingers, allowing the body to respond and relax. This technique aims to stimulate the body's innate healing mechanisms, encouraging improvements in pain levels and functional capacity. Sessions are typically structured to allow for periods of rest, giving the body time to process the treatment and enhancing its effects.

Study groups in NCT06675006
Study groupRoleWhat they receive
Bowen Therapy with Cryotherapy GroupThis group consists of participants receiving Bowen therapy combined with cryotherapy for the treatment acute ankle sprain. Each session includes a 30-minute Bowen therapy treatment, focusing on gentle, non-invasive movements designed to stimulate the body's healing processes. Cryotherapy involves the application of ice to the affected area to reduce inflammation and pain. Participants in this group will undergo three treatment sessions on days 1, 8, and 15 of the study, with assessments of pain intensity and functional capacity conducted before and after the intervention.
Medical Massage and Cryotherapy GroupThis group consists of participants who receive traditional medical massage for the treatment of acute ankle sprain. Interventions are conducted over three sessions, occurring on days 1, 8, and 15, with each session lasting 30 minutes. The medical massage aims to alleviate pain, improve muscle relaxation, and enhance overall functionality in daily activities. Participants' pain levels and functional capacity are assessed using the VAS pain scale and Roland-Morris questionnaire at both the beginning and end of the study period.
Receives: Combination Product: Medical Massage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity Reduction

    Pain intensity will be assessed using the Visual Analog Scale (VAS), which allows participants to rate their pain on a scale from 0 (no pain) to 10 (worst possible pain). This measure will be taken at baseline (Day 1) and at the end of the intervention period (Day 15) to evaluate the effectiveness of the interventions in reducing pain levels.

    Measured: 15 days

Secondary outcomes (1)

  1. Functional Improvement

    Functional status will be evaluated using the Roland-Morris Disability Questionnaire, which assesses the impact of ankle sprain on daily activities. Participants will complete this questionnaire at the start of the study and upon completion of the intervention to determine changes in functional ability and quality of life.

    Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2024
  2. Study start1 Jun 2024
  3. Primary completion1 Jul 2024
  4. Study completion1 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (actual)
Target duration
15 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06675006
Sponsor's protocol ID
B2024
Acronym
ICE-BOW
Status last verified
Nov 2024
First submitted
4 Nov 2024
Last updated
5 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Amjad F, Khalid A. Comparative effects of Bowen therapy and tennis ball technique on pain and functional disability in patients with thoracic myofascial pain syndrome. J Orthop Surg Res. 2023 Nov 24;18(1):895. doi: 10.1186/s13018-023-04379-z.

    PubMed 37996838

  • Marr M, Baker J, Lambon N, Perry J. The effects of the Bowen technique on hamstring flexibility over time: a randomised controlled trial. J Bodyw Mov Ther. 2011 Jul;15(3):281-90. doi: 10.1016/j.jbmt.2010.07.008. Epub 2010 Sep 15.

    PubMed 21665103

  • Sivakumar P, Dhinakaran S, Sudharshini. Bowen Therapy: An Overview. Pon J Nurs. 2022;15(1):16-18.

  • Tikhile P, Patil DS. Unveiling the Efficacy of Physiotherapy Strategies in Alleviating Low Back Pain: A Comprehensive Review of Interventions and Outcomes. Cureus. 2024 Mar 12;16(3):e56013. doi: 10.7759/cureus.56013. eCollection 2024 Mar.

    PubMed 38606230

  • Shokri P, Zahmatyar M, Falah Tafti M, Fathy M, Rezaei Tolzali M, Ghaffari Jolfayi A, Nejadghaderi SA, Sullman MJM, Kolahi AA, Safiri S. Non-spinal low back pain: Global epidemiology, trends, and risk factors. Health Sci Rep. 2023 Sep 4;6(9):e1533. doi: 10.1002/hsr2.1533. eCollection 2023 Sep.

    PubMed 37674621

Questions about this trial

What is this clinical trial studying?

An observational study of Ankle Sprains, run by Rehabilitation Centre Zivot at 1 site in Bosnia and Herzegovina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity Reduction (time frame: 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06675006, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.

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