Comparing Bowen Therapy With Ice to Medical Massage for Acute Ankle Sprain (ICE-BOW)

November 4, 2024 updated by: Darko Bilic, Rehabilitation Centre Zivot

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Bowen Therapy with Cryotherapy Group
This 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 Group
This 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.
Combination product: Medical Massage
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.
Other Names:
  • Cryotherapy
  • Bowen therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity Reduction
Time Frame: 15 days
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.
15 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Improvement
Time Frame: 15 days
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.
15 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 15 days
Participants will provide feedback regarding their satisfaction with the treatment received through a brief questionnaire administered at the end of the study. This will include questions related to their overall experience with the therapy, perceived effectiveness, and likelihood of recommending the treatment to others.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rehabilitation Centre Zivot

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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