NCT05948423

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.

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 2022

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 23, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

July 7, 2023

Last Update Submit

July 7, 2023

Conditions

Keywords

Tissue Flossing, Postoperative elbow stiffness

Outcome Measures

Primary Outcomes (3)

  • Liverpool Elbow Scoring Questionnaire (LES)

    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).

    6 months

  • Goniometer

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

    6 months

  • Visual Analogue Scale

    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).

    6 months

Study Arms (2)

(Group A) Tissue Flossing + Conventional Therapy

EXPERIMENTAL

1. Tissue Flossing (3reps of 6 different active and passive movements, total 1-2 mints) 2. Hot Pack (10 mints) 3. PNF technique on Bicep, Tricep, pronator, Supinator muscle (3reps\* 26sec, total 6 mints) 4. Joint Mobilization (3 reps of humeroulnar and radial head mobilization, total 6 mints) Total treatment duration was 24 mints.

Other: Tisue Flossing Technique

(Group B) Conventional Therapy

ACTIVE COMPARATOR

1. Hot Pack (10 mints) 2. PNF technique on Bicep, Tricep, pronator, supinator muscle (3reps\* 26sec, total 6 mints) 3. Joint Mobilization (3 reps of humeroulnar and radial head mobilization, total 6 mints) Total treatment duration was 24 mints.

Other: Tisue Flossing Technique

Interventions

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.

Also known as: Conventional Physical therapy
(Group A) Tissue Flossing + Conventional Therapy(Group B) Conventional Therapy

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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°

You may not qualify if:

  • Those patient who have allergy to latex
  • Skin diseases
  • Venous Thrombotic disease
  • Cardio Pulmonary illness with Grade 3and 4
  • Myositis Ossificance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Ordinance Factory Hospital

Islamabad, Punjab Province, 44000, Pakistan

Location

Related Publications (19)

  • Gracitelli MEC, Guglielmetti CLB, Botelho CAS, Malavolta EA, Assuncao JH, Ferreira Neto AA. Surgical Treatment of Post-traumatic Elbow Stiffness by Wide Posterior Approach. Rev Bras Ortop (Sao Paulo). 2020 Oct;55(5):570-578. doi: 10.1055/s-0039-1700827. Epub 2020 Jan 9.

    PMID: 33093721BACKGROUND
  • Liu W, Sun Z, Xiong H, Liu J, Lu J, Cai B, Wang W, Fan C. What are the prevalence of and factors independently associated with depression and anxiety among patients with posttraumatic elbow stiffness? A cross-sectional, multicenter study. J Shoulder Elbow Surg. 2022 Mar;31(3):469-480. doi: 10.1016/j.jse.2021.11.014. Epub 2021 Dec 27.

    PMID: 34968692BACKGROUND
  • Englert C, Zellner J, Koller M, Nerlich M, Lenich A. Elbow dislocations: a review ranging from soft tissue injuries to complex elbow fracture dislocations. Adv Orthop. 2013;2013:951397. doi: 10.1155/2013/951397. Epub 2013 Oct 21.

    PMID: 24228180BACKGROUND
  • Masci G, Cazzato G, Milano G, Ciolli G, Malerba G, Perisano C, Greco T, Osvaldo P, Maccauro G, Liuzza F. The stiff elbow: Current concepts. Orthop Rev (Pavia). 2020 Jun 25;12(Suppl 1):8661. doi: 10.4081/or.2020.8661. eCollection 2020 Jun 29.

    PMID: 32913596BACKGROUND
  • Ritali A, Rotini R, Cavallo M, Marinelli A, Guerra EJLS-J. Instability/stiffness in elbow fracture dislocation. 2020;34:30-5.

    BACKGROUND
  • Mittal R. Posttraumatic stiff elbow. Indian J Orthop. 2017 Jan-Feb;51(1):4-13. doi: 10.4103/0019-5413.197514.

    PMID: 28216745BACKGROUND
  • Zhang D, Nazarian A, Rodriguez EK. Post-traumatic elbow stiffness: Pathogenesis and current treatments. Shoulder Elbow. 2020 Feb;12(1):38-45. doi: 10.1177/1758573218793903. Epub 2018 Aug 8.

    PMID: 32010232BACKGROUND
  • Marinelli A, Bettelli G, Guerra E, Nigrisoli M, Rotini R. Mobilization brace in post-traumatic elbow stiffness. Musculoskelet Surg. 2010 May;94 Suppl 1:S37-45. doi: 10.1007/s12306-010-0068-5.

    PMID: 20383680BACKGROUND
  • Konrad A, Mocnik R, Nakamura M. Effects of Tissue Flossing on the Healthy and Impaired Musculoskeletal System: A Scoping Review. Front Physiol. 2021 May 21;12:666129. doi: 10.3389/fphys.2021.666129. eCollection 2021.

    PMID: 34093228BACKGROUND
  • Kiefer BN, Lemarr KE, Enriquez CC, Tivener KA, Daniel TJIJoAT, Training. A pilot study: perceptual effects of the voodoo floss band on glenohumeral flexibility. 2017;22(4):29-33.

    BACKGROUND
  • Kaneda H, Takahira N, Tsuda K, Tozaki K, Sakai K, Kudo S, et al. The effects of tissue flossing and static stretching on gastrocnemius exertion and flexibility. 2020;28(2):205-13.

    BACKGROUND
  • Borda J, Selhorst M. The use of compression tack and flossing along with lacrosse ball massage to treat chronic Achilles tendinopathy in an adolescent athlete: a case report. J Man Manip Ther. 2017 Feb;25(1):57-61. doi: 10.1080/10669817.2016.1159403. Epub 2016 May 30.

    PMID: 28855793BACKGROUND
  • Weber PJJoB, Therapies M. Flossing: An alternative treatment approach to Osgood-Schlatter's disease: Case report of an adolescent soccer player. 2018;22(4):860-1.

    BACKGROUND
  • . García-Luna MA, Cortell-Tormo JM, González-Martínez J, García-Jaén M. The effects of tissue flossing on perceived knee pain and jump performance: A pilot study. 2020.

    BACKGROUND
  • Hodeaux K. The effect of floss bands on elbow range of motion in tennis players: University of Arkansas; 2017.

    BACKGROUND
  • Stevenson P, Stevenson R, Duarte KWJJMBAS. Acute effects of the voodoo flossing band on ankle range of motion. 2019;7(6):244-53.

    BACKGROUND
  • Kielur DS, Powden CJ. Changes of Ankle Dorsiflexion Using Compression Tissue Flossing: A Systematic Review and Meta-Analysis. J Sport Rehabil. 2020 Oct 19;30(2):306-314. doi: 10.1123/jsr.2020-0129.

    PMID: 33075750BACKGROUND
  • Wilson RC, Jones PW. A comparison of the visual analogue scale and modified Borg scale for the measurement of dyspnoea during exercise. Clin Sci (Lond). 1989 Mar;76(3):277-82. doi: 10.1042/cs0760277.

    PMID: 2924519BACKGROUND
  • Sun Z, Fan C. Validation of the Liverpool Elbow Score for evaluation of elbow stiffness. BMC Musculoskelet Disord. 2018 Aug 21;19(1):302. doi: 10.1186/s12891-018-2226-0.

    PMID: 30126385BACKGROUND

Study Officials

  • Lal Gul Khan, MScNMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 17, 2023

Study Start

September 23, 2022

Primary Completion

June 20, 2023

Study Completion

June 28, 2023

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

The data will be treat confidentially and only use for the study purpose

Locations