NCT04993105

Brief Summary

study was conducted to check the effectiveness of graston on patients with chronic plantar fasciitis. After screening from inclusion exclusion criteria.Data will be randomly divided in two groups. Graston assisted release of plantar fascia is used for soft tissue mobilization. Pain level using NPRS, score on FADI and dorsiflexion restriction using LUNGE test will be performed before any treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

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

March 20, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

June 11, 2021

Last Update Submit

September 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • effects of graston on pain in patients with plantar fasciitis.

    Pain will be evaluated by NPRS on scale of to 10

    6 months

Secondary Outcomes (2)

  • effects of graston on range of motion in patients with plantar fasciitis.

    6 months

  • effects of graston assisted soft tissue mobilization on Foot and ankle function and disability.

    6 months

Study Arms (2)

B (exercise + graston):

EXPERIMENTAL

In graston + exercises treatment will be same but after exercises added with proper application of graston which included application of a cream to the posterior calf and plantar foot from the knee to the toes to reduce friction on the skin.The Graston tools will be then used to mobilize the tissues of the triceps surf and plantar foot. In areas of increased tissue restriction, more aggressive pressure with graston was applied using increased force and shorter strokes over the areas of restriction was offered as needed for pain management after each session. This will be continued for three sessions. NPRS score, score on FADI and dorsiflexors range will be assessed after treatment of two weeks. Along with conventional treatment. .

Other: Exercise + Graston.

A (exercise only)

ACTIVE COMPARATOR

Exercises only. Patients will be given gastrocnemius stretching, plantar fascia stretching, myofascial release and then graston will be given as sham treatment for 10 minutes after applying cream (applying graston on skin but not giving enough pressure).

Other: exercise only

Interventions

In graston + exercises treatment will be same but after exercises added with proper application of graston which included application of a cream to the posterior calf and plantar foot from the knee to the toes to reduce friction on the skin.The Graston tools will be then used to mobilize the tissues of the triceps surae and plantar foot. In areas of increased tissue restriction, more aggressive pressure with graston was applied using increased force and shorter strokes over the areas of restrictionIce was offered as needed for pain management after each session. This will be continued for three sessions. NPRS score, score on FADI and dorsiflexors range will be assessed after treatment of two weeks. Along with conventional treatment. .

Also known as: exercise only
B (exercise + graston):

gastrocnemius and plantarstretching

A (exercise only)

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study includes patients from the age group of 35 to 50 years.
  • The study includes patients with plantar heel pain from more than 6 weeks
  • The study includes patients with restricted dorsiflexion which will be measured by lunge's test
  • Pain in morning (decrease with activity)

You may not qualify if:

  • The study acute patient with plantar pain.
  • No history of serious underlying pathology, nerve root compromise, structural deformities, genetic spinal disorders or previous spinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rawal General and Dental Hospital

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (14)

  • Roxas M. Plantar fasciitis: diagnosis and therapeutic considerations. Altern Med Rev. 2005 Jun;10(2):83-93.

    PMID: 15989378BACKGROUND
  • Aldridge T. Diagnosing heel pain in adults. Am Fam Physician. 2004 Jul 15;70(2):332-8.

    PMID: 15291091BACKGROUND
  • Atkins D, Crawford F, Edwards J, Lambert M. A systematic review of treatments for the painful heel. Rheumatology (Oxford). 1999 Oct;38(10):968-73. doi: 10.1093/rheumatology/38.10.968.

    PMID: 10534547BACKGROUND
  • DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.

    PMID: 12851352BACKGROUND
  • Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003 May-Jun;93(3):234-7. doi: 10.7547/87507315-93-3-234.

    PMID: 12756315BACKGROUND
  • Muth CC. Plantar Fasciitis. JAMA. 2017 Jul 25;318(4):400. doi: 10.1001/jama.2017.5806. No abstract available.

    PMID: 28742914BACKGROUND
  • Hammer WI, Pfefer MT. Treatment of a case of subacute lumbar compartment syndrome using the Graston technique. J Manipulative Physiol Ther. 2005 Mar-Apr;28(3):199-204. doi: 10.1016/j.jmpt.2005.02.010.

    PMID: 15855909BACKGROUND
  • Howitt S, Wong J, Zabukovec S. The conservative treatment of Trigger thumb using Graston Techniques and Active Release Techniques. J Can Chiropr Assoc. 2006 Dec;50(4):249-54.

    PMID: 17549185BACKGROUND
  • Martin RL, Davenport TE, Reischl SF, McPoil TG, Matheson JW, Wukich DK, McDonough CM; American Physical Therapy Association. Heel pain-plantar fasciitis: revision 2014. J Orthop Sports Phys Ther. 2014 Nov;44(11):A1-33. doi: 10.2519/jospt.2014.0303.

    PMID: 25361863BACKGROUND
  • Looney B, Srokose T, Fernandez-de-las-Penas C, Cleland JA. Graston instrument soft tissue mobilization and home stretching for the management of plantar heel pain: a case series. J Manipulative Physiol Ther. 2011 Feb;34(2):138-42. doi: 10.1016/j.jmpt.2010.12.003.

    PMID: 21334547BACKGROUND
  • Daniels CJ, Morrell AP. Chiropractic management of pediatric plantar fasciitis: a case report. J Chiropr Med. 2012 Mar;11(1):58-63. doi: 10.1016/j.jcm.2011.06.009.

    PMID: 22942843BACKGROUND
  • Jones ER, Finley MA, Fruth SJ, McPoil TG. Instrument-Assisted Soft-Tissue Mobilization for the Management of Chronic Plantar Heel Pain: A Pilot Study. J Am Podiatr Med Assoc. 2019 May;109(3):193-200. doi: 10.7547/16-105. Epub 2019 Mar 27.

    PMID: 30916579BACKGROUND
  • Miners AL, Bougie TL. Chronic Achilles tendinopathy: a case study of treatment incorporating active and passive tissue warm-up, Graston Technique, ART, eccentric exercise, and cryotherapy. J Can Chiropr Assoc. 2011 Dec;55(4):269-79.

    PMID: 22131563BACKGROUND
  • Young IA PT, DSc, Dunning J PT, DPT, Butts R PT, PhD, Mourad F PT, DPT, Cleland JA PT, PhD. Reliability, construct validity, and responsiveness of the neck disability index and numeric pain rating scale in patients with mechanical neck pain without upper extremity symptoms. Physiother Theory Pract. 2019 Dec;35(12):1328-1335. doi: 10.1080/09593985.2018.1471763. Epub 2018 Jun 1.

    PMID: 29856244BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lal Gul Khan, MScPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: study will evaluate the effects of Graston assisted soft tissue mobilization on the patients with plantar fasciitis .Study will include two groups , one will be treated with graston and one will be treated without graston in the time period of two weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2021

First Posted

August 6, 2021

Study Start

March 20, 2021

Primary Completion

July 30, 2021

Study Completion

July 31, 2021

Last Updated

September 20, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations