NCT06675006

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

November 4, 2024

Last Update Submit

November 4, 2024

Conditions

Keywords

Bowen therapyCryotherapy

Outcome Measures

Primary Outcomes (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.

    15 days

Secondary Outcomes (1)

  • Functional Improvement

    15 days

Other Outcomes (1)

  • Patient Satisfaction

    15 days

Study Arms (2)

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

Interventions

Medical MassageCOMBINATION_PRODUCT

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.

Also known as: Bowen therapy, Cryotherapy
Medical Massage and Cryotherapy Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Centre Život

Mostar, 88000, Bosnia and Herzegovina

Location

Related Publications (5)

  • 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.

    PMID: 37996838BACKGROUND
  • 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.

    PMID: 21665103BACKGROUND
  • Sivakumar P, Dhinakaran S, Sudharshini. Bowen Therapy: An Overview. Pon J Nurs. 2022;15(1):16-18.

    BACKGROUND
  • 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.

    PMID: 38606230BACKGROUND
  • 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.

    PMID: 37674621BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 5, 2024

Study Start

June 1, 2024

Primary Completion

July 1, 2024

Study Completion

October 1, 2024

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations