Clincosm LogoSign in Get a demo

Tissue Flossing Technique on Post Traumatic Elbow Stiffness.

Sponsor
Riphah International University (Other)
Overall Status
Completed
CT.gov ID
NCT05948423
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
9.1
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research is to determine the effect of tissue flossing technique on post-traumatic elbow stiffness, Pain and ROM. A randomized control trial was conducted at Pakistan ordinance factory (POF) Hospital Wah Cantt, Pakistan. The sample size was 36 calculated from G-power. 6 participants were excluded from the study and remaining 30 participants were divided into two groups, each having 15 participants. The study duration was six months. Sampling technique was applied was Non probability Convenience Sampling technique for recruitment and group randomization using random selection of participants. Both post-traumatic and post-operative male and female participants of aged 18-45 years with flexion <120° and loss of extension >30°. Tools used in this study are Liverpool elbow Score Questionnaire (LES), Goniometer and Visual Analogue Scale (VAS). Data was analyzed through SPSS version 23.

Condition or Disease Intervention/Treatment Phase
  • Other: Tisue Flossing Technique
 N/A

Detailed Description

Post traumatic or operative stiffness at elbow is quite common problem causes higher level of impairments in daily living activities i.e. use of mobile or computer, personal hygiene, dressing, eating, cooking that requires higher degree of elbow range of motion and adversely effects the quality of life (1).

The common reason of stiffness in elbow is trauma with rates ranging from 3% to 20% (1). Incidence of (PTES) is increased up to 56% after elbow trauma (2). Simultaneously radial head and elbow injuries increase incidence rate up to 90%, and 5-10% patients are effected by PTES even with an isolated injury to the radial head (3). Another study shows that exact incidence of elbow stiffness is not known but elbow injuries causes stiffness in approximately 12% of patients (1). Elbow stiffness causes can be categorized as traumatic, atraumatic and congenital (4).

Patients with well reduced and stabilized fracture are also suffer for soft tissue and capsule thickening leads to range of motion limitation. Stiff elbow has thickened capsule with high level of myofibroblast. This causes alteration in the auto-regulation of (TGF-β) transforming growth factor-beta. The influence of myofibroblasts is increased in initial period after trauma but deficient in chronic stiffness (>5 months) (4).

Treatment depends upon the cause of stiffness, stiffness time, severity of stiffness and involved movement of elbow (5). Treatment include CPM (continuous Passive motion), manipulation, stretching, active and passive exercises, mobilization, passive resistance exercises, passive mobilization with movements and PNF (proprioceptive neuromuscular facilitation technique) (6, 7). Physiotherapy is commonly used treatment both for prevention of post traumatic elbow stiffness and regain motion after surgery (7). Factors effecting PTES consist of patients and characteristics of fracture and treatment of fracture causes stiffness, pain, instability and functional limitations of elbow (4).

Clinically according to the severity, elbow stiffness is classified as very severe ( flexion/ extension arc <30), severe ( 30-60), moderate ( 61-90), minimal ( >90) (8). Diagnosis depends upon history, imaging and physical examination. Plain radiographs are useful to see joint congruity, osteophytes and myositis mass (6).

Different studies have been conducted to show influence of tissue flossing on ROM, majority of these studies have shown positive effects on range of motion (9).

A systematic and evidence based search of relevant literature was performed by utilizing Google Scholar as Search engine and the Key words used were Elbow stiffness, Tissue Flossing, Post- Operative elbow stiffness. The purpose of the Literature review is to find out the pre-existing literature regarding the Tissue flossing effects.

In 2017 kiefer et al, conducted a pilot study on the tissue flossing effects and glenohumeral flexibility and concluded that flexibility in posttest is significantly increased (10).

In 2020 Kaneda et al. conducted an experimental research on tissue flossing effect and stretching on calf muscles in which 20 healthy young men participated and concluded that prep and post changes in dorsiflexion was significantly increase with flossing compare to rest (11).

Although enough researches have not been conducted in disease population but some studies have shown its beneficial effect in reducing pain and improve range of motion in diseases population (12, 13).

In 2017, Borda and Selhorst conducted a case study on 14 years old female with chronic pain with 8/10 intensity of Achilles tendinopathy and only two session with tissue flossing shows improvement in pain with 0/10 and disability during sports (12).

In 2018, weber et al. conducted a study on 14 years old male soccer player with Osgood-Schlatter's disease and concluded that there is significant improvement on muscle functions and pain with nine weeks flossing intervention plan (13).

In 2020 by Marco et al. a pilot study was conducted on five young male athletes with knee pain and shows significant improvement on knee pain and jump performance with flossing technique (14).

In 2017 a research was conducted on twelve elite healthy tennis players in which floss band wrapped with 50% stretch on elbow joint and perform 6 passive exercises in three mints and concluded that there is significant improvement in elbow range of motion in floss band group (15).

In 2019, Stevenson conducted a research on 5 male athletes who had stiffness, tightness, heel pain or calf pain and concluded that there was a significant difference between floss group and control group (16).

In 2020, Kielur and powden perform systematic review and meta-analysis in which 6 articles were enrolled and concluded that floss band is an effective method for endurance, strength and physical functions (17)

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Tissue Flossing Technique in Patients With Post Traumatic Elbow Stiffness.
Actual Study Start Date :
Sep 23, 2022
Actual Primary Completion Date :
Jun 20, 2023
Actual Study Completion Date :
Jun 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: (Group A) Tissue Flossing + Conventional Therapy

Tissue Flossing (3reps of 6 different active and passive movements, total 1-2 mints) Hot Pack (10 mints) PNF technique on Bicep, Tricep, pronator, Supinator muscle (3reps* 26sec, total 6 mints) Joint Mobilization (3 reps of humeroulnar and radial head mobilization, total 6 mints) Total treatment duration was 24 mints.

Other: Tisue Flossing Technique
Experimental Group (Tissue Flossing + conventional therapy) Tissue Flossing involved active and passive movement with elbow wrapped with a floss band made from latex rubber (7m x 2 inch) Floss band was wrapped around the elbow (distal to proximal) using 25% overlapping pattern with an elongation stretch of 25%. During treatment the compression of floss band was measured with modified sphygmomanometer by placing cuff under floss band (which is applied on muscle) and note the pressure on manometer. Control Group (Conventional Therapy) Conventional therapy was applied for 23 minutes for both groups which include hot pack for 10 minutes, PNF (hold-relax with agonist contraction): It started with a gentle stretch of bicep muscle for 10 seconds followed by isometric contraction for 6 seconds then the patient tried to flex their elbow and the therapist also assisted.
Other Names:
  • Conventional Physical therapy

    		•
    Active Comparator: (Group B) Conventional Therapy

    Hot Pack (10 mints) PNF technique on Bicep, Tricep, pronator, supinator muscle (3reps* 26sec, total 6 mints) Joint Mobilization (3 reps of humeroulnar and radial head mobilization, total 6 mints) Total treatment duration was 24 mints.

    Other: Tisue Flossing Technique
    Experimental Group (Tissue Flossing + conventional therapy) Tissue Flossing involved active and passive movement with elbow wrapped with a floss band made from latex rubber (7m x 2 inch) Floss band was wrapped around the elbow (distal to proximal) using 25% overlapping pattern with an elongation stretch of 25%. During treatment the compression of floss band was measured with modified sphygmomanometer by placing cuff under floss band (which is applied on muscle) and note the pressure on manometer. Control Group (Conventional Therapy) Conventional therapy was applied for 23 minutes for both groups which include hot pack for 10 minutes, PNF (hold-relax with agonist contraction): It started with a gentle stretch of bicep muscle for 10 seconds followed by isometric contraction for 6 seconds then the patient tried to flex their elbow and the therapist also assisted.
    Other Names:
  • Conventional Physical therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Liverpool Elbow Scoring Questionnaire (LES) [6 months]

      Liverpool elbow Score is valid questionnaire specifically used to assess the functional scoring of elbow joint in elbow stiffness patients. LES contains nine-item (PAQ, P1-P9) patient-answered questionnaire along with six-item (CAS, C1-C6) clinical assessment score. All PAQ and CAS items were calculated with 0 to 10 numbers scale in which the lesser scores denoted greater symptom and functional severity. This scale has Good-to-excellent validity (0.45-0.89) (23).

    2. Goniometer [6 months]

      Universal goniometer measurements at Elbow ROM. The reliability ranged from 0.93 to 0.98 for the goniometric measurements (19).

    3. Visual Analogue Scale [6 months]

      Pain intensity of elbow was measured by using Visual Analogue scale (VAS). VAS is mostly used assessment tool for intensity of pain in rehabilitation. It consists of unmarked 10cm horizontal line in which a patient mark on the line the point that they feel represents the perception of their pain ranges from '0cm' no pain to '100cm' very severe pain. The validity of VAS is 0.7 and reliability is (0.5) (48).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age group between 18-45 years

    • Both male and female

    • Complete bone healing

    • Immobilization period 4-10 weeks

    • Flexion <120° and loss of extension >30°

    Exclusion Criteria:

    • Those patient who have allergy to latex

    • Skin diseases

    • Venous Thrombotic disease

    • Cardio Pulmonary illness with Grade 3and 4

    • Myositis Ossificance

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pakistan Ordinance Factory Hospital Islamabad Punjab Pakistan 44000

    Sponsors and Collaborators

    • Riphah International University

    Investigators

    • Principal Investigator: Lal Gul Khan, MScNMPT, Riphah International University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Riphah International University
    ClinicalTrials.gov Identifier:
    NCT05948423
    Other Study ID Numbers:
    • Riphah IU Maria Ajaz Mughal
    First Posted:
    Jul 17, 2023
    Last Update Posted:
    Jul 17, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Riphah International University
    Tissue Flossing, Postoperative elbow stiffness

    Study Results

    No Results Posted as of Jul 17, 2023