NCT04145180

Brief Summary

People receiving a head and neck cancer treatment often do not find an adequate therapeutic response for the side effects derived from this treatment. The objective of this study is to assess the effectiveness of a physical recovery program based on manual therapy over these problems. Previous studies have shown the effectiveness of this type of programs on patients who have had cancer in other locations with clinically relevant results. There is a shortage of proposals for this subgroup of patients that require special attention. This project intends to carry out an experimental randomized controlled study with 84 patients treated of head and neck cancer who will be assigned randomly to the study groups: a) manual therapy program or, b) control group. The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 months of patient follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Sep 2019

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 2, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

2.3 years

First QC Date

October 9, 2019

Last Update Submit

January 8, 2024

Conditions

Head and Neck CancerPainDysfunction

Keywords

PainFunctionQuality of LifeHead and Neck Cancer

Outcome Measures

Primary Outcomes (5)

  • Health-related quality of life

    Questionnaire EORTC QLQ-C30 was used for measuring quality of life

    6 weeks

  • Health-related quality of life - 2

    Questionnaire EORTC QLQ-H\&N-35 was used for measuring quality of life specifically in survivors of head and neck cancer

    6 weeks

  • Pain Intensity

    Visual Analogue Scale was used for evaluating pain intensity at cervical, temporomandibular joint, face and shoulder levels bilaterally. This consisted of a 10 cm horizontal line with the words "no pain" at the left extreme (0) and "pain as bad as it could be" at the right extreme (10)

    6 weeks

  • Pressure pain thresholds

    Pressure algometry (Force Dial DFK 20 analogue algometer, Wagner, Greenwich, USA) was assessed over the temporalis, masseter, upper trapezius and levator scapulae muscles and the C5-C6 zygapophyseal joint, the sternoclavicular joint and the tibialis anterior muscle as a distant reference muscle.

    6 weeks

  • Shoulder and cervical active range of motion

    Shoulder active range of motion (AROM) was assessed with a two-arms goniometer joined by a 360º protractor with the patient lying on a supine position. Cervical AROM was measured in a upright sitting position with a range of motion instrument (Performance Attainment Associates, Spine Products)

    6 weeks

Secondary Outcomes (13)

  • Shoulder pain and disability perception

    6 weeks

  • Isometric handgrip strength

    6 weeks

  • Deep cervical flexors endurance

    6 weeks

  • Physical Fitness

    6 weeks

  • Maximal mouth opening

    6 weeks

  • +8 more secondary outcomes

Study Arms (2)

Manual Therapy

EXPERIMENTAL

Manual Therapy-based intervention

Other: Manual therapy

Control

NO INTERVENTION

Patients waiting list

Interventions

Manual therapyOTHER

40 minutes of physiotherapy, based on manual therapy sessions over 6 weeks. Three times a week.

Manual Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To have ended their treatment in the previous 6-24 months
  • To have no metastasis or active cancer
  • To have cervical and/or temporomandibular joint pain \>3 in a Visual Analogue Scale

You may not qualify if:

  • Mental or physical illness preventing subjects from participating in the study
  • Previous chronic pain conditions
  • Previous cervical or temporomandibular joint pain
  • Previous dysphagia disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolina Fernández Lao

Granada, 18014, Spain

Location

Related Publications (11)

  • De Groef A, Van Kampen M, Vervloesem N, Dieltjens E, Christiaens MR, Neven P, Vos L, De Vrieze T, Geraerts I, Devoogdt N. Effect of myofascial techniques for treatment of persistent arm pain after breast cancer treatment: randomized controlled trial. Clin Rehabil. 2018 Apr;32(4):451-461. doi: 10.1177/0269215517730863. Epub 2017 Sep 15.

    PMID: 28914087BACKGROUND

  • Sheikh A, Shallwani H, Ghaffar S. Postoperative shoulder function after different types of neck dissection in head and neck cancer. Ear Nose Throat J. 2014 Apr-May;93(4-5):E21-6.

    PMID: 24817237BACKGROUND

  • Oz B, Memis A. Development of musculoskeletal complaints and functional disabilities in patients with laryngeal carcinoma after neck dissection sparing spinal accessory nerve. Eur J Cancer Care (Engl). 2009 Mar;18(2):179-83. doi: 10.1111/j.1365-2354.2008.00950.x. No abstract available.

    PMID: 19267734BACKGROUND

  • Binczak M, Navez M, Perrichon C, Blanchard D, Bollet M, Calmels P, Couturaud C, Dreyer C, Espitalier F, Testelin S, Albert S, Moriniere S; SFORL Work Group. Management of somatic pain induced by head-and-neck cancer treatment: definition and assessment. Guidelines of the French Oto-Rhino-Laryngology- Head and Neck Surgery Society (SFORL). Eur Ann Otorhinolaryngol Head Neck Dis. 2014 Sep;131(4):243-7. doi: 10.1016/j.anorl.2014.07.003. Epub 2014 Aug 6.

    PMID: 25108356BACKGROUND

  • Cantarero-Villanueva I, Fernandez-Lao C, Fernandez-de-Las-Penas C, Lopez-Barajas IB, Del-Moral-Avila R, de la-Llave-Rincon AI, Arroyo-Morales M. Effectiveness of water physical therapy on pain, pressure pain sensitivity, and myofascial trigger points in breast cancer survivors: a randomized, controlled clinical trial. Pain Med. 2012 Nov;13(11):1509-19. doi: 10.1111/j.1526-4637.2012.01481.x. Epub 2012 Sep 7.

    PMID: 22958507BACKGROUND

  • Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.

    PMID: 3785962BACKGROUND

  • van Wilgen CP, Dijkstra PU, van der Laan BF, Plukker JT, Roodenburg JL. Shoulder and neck morbidity in quality of life after surgery for head and neck cancer. Head Neck. 2004 Oct;26(10):839-44. doi: 10.1002/hed.20052.

    PMID: 15390203BACKGROUND

  • Cardoso LR, Rizzo CC, de Oliveira CZ, dos Santos CR, Carvalho AL. Myofascial pain syndrome after head and neck cancer treatment: Prevalence, risk factors, and influence on quality of life. Head Neck. 2015 Dec;37(12):1733-7. doi: 10.1002/hed.23825. Epub 2014 Sep 25.

    PMID: 24986588BACKGROUND

  • Sist T, Miner M, Lema M. Characteristics of postradical neck pain syndrome: a report of 25 cases. J Pain Symptom Manage. 1999 Aug;18(2):95-102. doi: 10.1016/s0885-3924(99)00054-8.

    PMID: 10484856BACKGROUND

  • Gane EM, Michaleff ZA, Cottrell MA, McPhail SM, Hatton AL, Panizza BJ, O'Leary SP. Prevalence, incidence, and risk factors for shoulder and neck dysfunction after neck dissection: A systematic review. Eur J Surg Oncol. 2017 Jul;43(7):1199-1218. doi: 10.1016/j.ejso.2016.10.026. Epub 2016 Nov 17.

    PMID: 27956321BACKGROUND

  • Gane EM, McPhail SM, Hatton AL, Panizza BJ, O'Leary SP. The relationship between physical impairments, quality of life and disability of the neck and upper limb in patients following neck dissection. J Cancer Surviv. 2018 Oct;12(5):619-631. doi: 10.1007/s11764-018-0697-5. Epub 2018 May 16.

    PMID: 29770954BACKGROUND

MeSH Terms

Conditions

Head and Neck NeoplasmsPain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Carolina Fernández-Lao, PhD

    Universidad de Granada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Carolina Fernández-Lao

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 30, 2019

Study Start

September 2, 2019

Primary Completion

December 20, 2021

Study Completion

January 30, 2022

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations

ES(1)