NCT06185231

Brief Summary

Over the past decade, vibration therapy has gained popularity. This treatment involves the transmission of vibration either through whole-body vibration (WBV) platforms or by applying local vibration (LV) directly to the muscles or tendons. In the context of ACLR (anterior cruciate ligament reconstruction), it has been reported that a single session of either WBV or LV, applied while patients maintain a squatting position, acutely improves the strength of the Quadriceps muscle when applied 50 months post-surgery, possibly by reducing arthrogenic muscle inhibition. Another study tested whether local vibration training (LVT) in the early post-ACLR phase (first 10 weeks) could improve strength recovery and found that LVT enhances strength regain after ACLR. This feasibility study demonstrates that LVT applied to relaxed muscles is a promising method of vibration therapy that can be applied early in ACLR. Compared to traditional massage, vibration therapy may also improve strength parameters. Percussion massage therapy is a new method that combines elements of traditional massage and vibration therapy. In the literature, there is a lack of scientific evidence on how and to what extent percussion massage therapy affects range of motion (ROM) and muscle strength. To date, only one conference paper has investigated the effects of a handheld percussion massage therapy device, and they found no change in vertical jump height after a 5-minute percussion massage therapy session applied to several lower body muscle groups." A review of the literature reveals that to date, there has been no study investigating the effects of manually applied percussion massage therapy on pain, functionality, and proprioception in cases who have undergone anterior cruciate ligament surgery. Therefore, the purpose of our study is to examine the effects of percussion massage therapy on pain, joint range of motion, joint position sense, muscle diameter, balance parameters, and functionality in patients who have undergone surgery following an anterior cruciate ligament injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

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

September 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

November 28, 2023

Last Update Submit

June 30, 2024

Conditions

Keywords

VibrationAnterior Cruciate Ligamentjoint position sense

Outcome Measures

Primary Outcomes (4)

  • Range of motion

    For knee joint range of motion assessment with a smartphone, subjects are positioned prone. The smartphone is placed on the lateral midline of the tibia to establish 0° knee joint extension, then active knee flexion is performed, and angular data is obtained, followed by passive knee flexion performed by the practitioner and angular data is taken again.

    Baseline

  • Joint Position Sense

    For the assessment of knee joint position sense, the starting position is considered as 90° flexion. For the first target angle of 60° knee flexion, the physiotherapist passively brings the patient's knee to 60° knee flexion, holds it in that position for 5 seconds, and asks the patient to remember this angle and say "here" when they think they have reached this angle during the test. The physiotherapist returns the patient's knee to the starting position of 90° knee flexion and asks the patient to rest in the starting position for 5 seconds. Before proceeding with the test, the target angle is repeated 3 times with eyes open and 3 times with eyes closed, and the patient's "perceived target angle" in degrees is recorded.

    Baseline

  • Visual Analog Scale

    The Visual Analog Scale is used to measure the intensity of pain. The patient is asked to assess their pain on a line with values ranging from 0-10, where 0 means no pain, and 10 means unbearable pain. Individuals mark their pain intensity on this line according to their pain situation.

    Baseline

  • Berg Balance Scale

    The scale includes 14 different activities assessing functions such as getting up from sitting, sitting without support, standing without support, sitting while standing, standing with eyes closed, transfers, standing with legs together, picking up objects from the floor, reaching forward while standing, looking back while turning, turning 360 degrees, standing on a stable side stool, standing with one foot in front, and standing on one foot. Each activity is scored between 0-4. The scoring of the scale is done by adding up the scores from each section. According to the results obtained from the scale; ≤20 indicates wheelchair level, \>20≤40 indicates walking with assistance, and \>40≤56 indicates independence.

    Baseline

Secondary Outcomes (2)

  • Western Ontario and McMaster Universities Osteoarthritis Index

    Baseline

  • Short Form-36

    Baseline

Study Arms (2)

Percussion Massage Group

EXPERIMENTAL

Both groups will undergo a progressive exercise program given as Phase-1, Phase-2, and Phase-3 for 6 weeks. The Percussion massage group will receive percussion massage therapy for a total of 5 minutes for each muscle group.The application will be done to the Quadriceps and Hamstring muscle groups before exercise. The device will be used with a soft connection head at 33-40 Hz. A total of 5 minutes of percussion massage will be applied to each muscle group. In the first 2.5 minutes of the massage therapy, the medial side of the focus muscle will be targeted, and in the second 2.5 minutes, the lateral side of the focus muscle will be targeted. Neuromuscular Electrical Stimulation (NMES) will be applied to the Quadriceps muscle group for facilitation and reeducation purposes.

Other: Percussion Massage Group

Conventional Group

ACTIVE COMPARATOR

Conventional group undergo a progressive exercise program given as Phase-1, Phase-2, and Phase-3 for 6 weeks. Neuromuscular Electrical Stimulation (NMES) will be applied to the Quadriceps muscle group for facilitation and reeducation purposes. NMES Parameters: Electrode placement: will be applied to motor points and the muscle belly to achieve optimal contraction. Frequency: 50-70 Hz Duration: 20 minutes.

Other: Conventional Group

Interventions

In addition progressive exercise program, The Percussion massage group will receive percussion massage therapy for a total of 5 minutes for each muscle group. The application will be done to the Quadriceps and Hamstring muscle groups before exercise. Neuromuscular Electrical Stimulation (NMES) will be applied to the Quadriceps muscle group for facilitation and reeducation purposes.

Percussion Massage Group

Conventional group undergo a progressive exercise program given as Phase-1, Phase-2, and Phase-3 for 6 weeks. Neuromuscular Electrical Stimulation (NMES) will be applied to the Quadriceps muscle group for facilitation and reeducation purposes.

Conventional Group

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having a hamstring tendon autograft, allograft, or undergone anterior cruciate ligament reconstruction Complete unilateral ACL rupture
  • Applying to the physical therapy clinic within the first two weeks after surgical reconstruction
  • Being in the age range of 20-40
  • Agreeing to participate in the study
  • Having signed the informed consent form

You may not qualify if:

  • Presence of other intra-articular and extra-articular ligament/cartilage pathology in addition to the ACL rupture
  • History of secondary reconstruction surgery
  • Diagnosis of specific mechanical (alignment) disorder of the lower extremity
  • Presence of central and peripheral nervous system diseases
  • Diseases affecting the musculoskeletal, neurological, and vestibular systems
  • Presence of chronic and systemic diseases that may cause peripheral neuropathy and loss of deep sensation (e.g., diabetes, chronic kidney failure)
  • Presence of cognitive, mental, and psychological problems
  • Presence of balance problems or use of medication that negatively affects balance
  • History of accompanying autoimmune or inflammatory diseases such as rheumatoid arthritis, lupus erythematosus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34820, Turkey (Türkiye)

Location

Related Publications (1)

  • Erayata BN, Menek B. Investigating the effects of percussion massage therapy on pain, functionality, muscle diameter, and proprioception in individuals with ACL reconstruction: a randomized controlled trial. PLoS One. 2025 Mar 26;20(3):e0319731. doi: 10.1371/journal.pone.0319731. eCollection 2025.

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Burak Menek

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 29, 2023

Study Start

September 15, 2023

Primary Completion

June 15, 2024

Study Completion

June 30, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations