NCT02624635

Brief Summary

The purpose of this study is to compare the effects of manual therapy and of manual therapy associated with hip strengthening in the recovery of patients with heel pain. Heel pain decreases function, balance, walking and can cause change in the movement pattern. This alterations can induce a deficit in motor control of other structures as knee and hip. There is an importance to compare the effects of manual therapy and manual therapy associated with hip strengthening on the recover of patients with heel pain.

Trial Health

57
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Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

2.2 years

First QC Date

December 1, 2015

Last Update Submit

March 12, 2018

Conditions

Keywords

Manual TherapyPainHipMuscle Strength

Outcome Measures

Primary Outcomes (1)

  • Level of intensity of pain

    Level of intensity of pain assessed through the numerical pain scale.

    Up to three months

Secondary Outcomes (2)

  • Functional Status

    Up to three months

  • Pressure pain threshold

    Up to three months

Study Arms (2)

Manual Therapy

ACTIVE COMPARATOR

The treatment for this group will be manual therapy.

Other: Manual Therapy

Manual Therapy and Hip Strengthening

EXPERIMENTAL

It will be done the same treatment performed in group 1 plus the strengthening of the muscles of the hip.

Other: Manual Therapy and Hip Strengthening

Interventions

The scheme established for that intervention is as follows: joint manipulation passive ankle and foot, myofascial release technique (gastrocnemius, soleus muscle and plantar fascia), neural mobilization (nerve tibial) and stretching the plantar region and sural triceps, following the recommendations described by Mcpoil et al. (2008).

Manual Therapy

It will be done the same treatment performed in group 1 plus the strengthening of the muscles of the hip (iliac muscle, psoas, gluteus maximus, gluteus medius and gluteus minimus) and the treatment schedule established for this intervention is the use of exercises with progressive resistance. Will be performed 3 sets of 10 reps with 30 seconds rest between each set, according to the guidelines of the American College of Sports Medicine (ACSM, 2014). The home exercises consist of repeating the same procedures performed for supervised strengthening. The calculation of the ideal individual load will be carried by Brzycki formula, i.e. one repetition maximum (1RM) = weight ÷ \[1.0278 - (0.0278 x number of repetitions)\] as was used by (Shirazi et al., 2007).

Manual Therapy and Hip Strengthening

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with heel pain, that increases on the first steps after a period without activity and with long periods on standing position, regardless of age and gender and that didn't went under any physiotherapeutic treatment in the last 3 months.

You may not qualify if:

  • Patients who have a history of surgery on the lower limb on the past 6 months; patients with bilateral heel pain; patients under psychiatric treatment; patients that went under a manual therapy scheme treatment for heel pain before; rheumatic syndromes; patients who receive some benefit labor or patients underage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitário Gaffréé Guinle

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Related Publications (7)

  • Acevedo JI, Beskin JL. Complications of plantar fascia rupture associated with corticosteroid injection. Foot Ankle Int. 1998 Feb;19(2):91-7. doi: 10.1177/107110079801900207.

    PMID: 9498581BACKGROUND
  • Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial. Foot (Edinb). 2014 Jun;24(2):66-71. doi: 10.1016/j.foot.2014.03.005. Epub 2014 Mar 21.

    PMID: 24703512BACKGROUND
  • Moore AR, Eccleston C, Derry S, Wiffen P, Bell RF, Straube S, McQuay H; ACTINPAIN writing group of the IASP Special Interest Group (SIG) on Systematic Reviews in Pain Relief and the Cochrane Pain, Palliative and Supportive Care Systematic Review Group editors. "Evidence" in chronic pain--establishing best practice in the reporting of systematic reviews. Pain. 2010 Sep;150(3):386-389. doi: 10.1016/j.pain.2010.05.011. Epub 2010 Jun 2. No abstract available.

    PMID: 20627575BACKGROUND
  • Babcock MS, Foster L, Pasquina P, Jabbari B. Treatment of pain attributed to plantar fasciitis with botulinum toxin a: a short-term, randomized, placebo-controlled, double-blind study. Am J Phys Med Rehabil. 2005 Sep;84(9):649-54. doi: 10.1097/01.phm.0000176339.73591.d7.

    PMID: 16141740BACKGROUND
  • Bergmann JN. History and mechanical control of heel spur pain. Clin Podiatr Med Surg. 1990 Apr;7(2):243-59.

    PMID: 2189536BACKGROUND
  • Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.

    PMID: 10201543BACKGROUND
  • Buch M, Knorr U, Fleming L, Theodore G, Amendola A, Bachmann C, Zingas C, Siebert WE. [Extracorporeal shockwave therapy in symptomatic heel spurs. An overview]. Orthopade. 2002 Jul;31(7):637-44. doi: 10.1007/s00132-002-0323-z. German.

    PMID: 12219661BACKGROUND

MeSH Terms

Conditions

Fasciitis, PlantarPain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Leandro AC Nogueira, PhD

    Centro Universitário Augusto Motta

    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

December 1, 2015

First Posted

December 8, 2015

Study Start

January 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations